| 5/9/2007 |
BK060035 |
Blood Establishment Computer Software And Accessories |
Mak-System |
Hematology |
Blood Establishment Computer Software And Accessories |
| 4/23/2007 |
BK060056 |
Blood Establishment Computer Software And Accessories |
Prescott Ideas LLC |
Hematology |
Blood Establishment Computer Software And Accessories |
| 10/26/2007 |
BK070062 |
Blood Establishment Computer Software And Accessories |
Mak-System |
Hematology |
Blood Establishment Computer Software And Accessories |
| 5/13/2008 |
BK080002 |
Blood Establishment Computer Software And Accessories |
Mak-System |
Hematology |
Blood Establishment Computer Software And Accessories |
| 11/16/2010 |
BK100057 |
Blood Establishment Computer Software And Accessories |
Mediware Information Systems, Inc. |
Hematology |
Blood Establishment Computer Software And Accessories |
| 9/19/2012 |
BK120036 |
Blood Establishment Computer Software And Accessories |
Mediware Information Systems, Inc. |
Hematology |
Blood Establishment Computer Software And Accessories |
| 9/5/2012 |
BK120039 |
Blood Establishment Computer Software And Accessories |
Mediware Information Systems, Inc. |
Hematology |
Blood Establishment Computer Software And Accessories |
| 9/30/2016 |
BK160066 |
Blood Establishment Computer Software And Accessories |
Mediware Information Systems, Inc. |
Hematology |
Blood Establishment Computer Software And Accessories |
| 7/3/2018 |
BK180200 |
Blood Establishment Computer Software And Accessories |
Mediware Information Systems, Inc. |
Hematology |
Blood Establishment Computer Software And Accessories |
| 11/8/2018 |
BK180245 |
Blood Establishment Computer Software And Accessories |
Data Innovations LLC |
Hematology |
Blood Establishment Computer Software And Accessories |
| 12/3/2019 |
BK190333 |
Blood Establishment Computer Software And Accessories |
Terumo BCT, Inc |
Hematology |
Blood Establishment Computer Software And Accessories |
| 10/4/2022 |
BK220744 |
Blood Establishment Computer Software And Accessories |
Diagnostic Grifols, S. A. |
Hematology |
Blood Establishment Computer Software And Accessories |
| 6/26/2023 |
BK220791 |
Blood Establishment Computer Software And Accessories |
GPI USA, Inc. |
Hematology |
Blood Establishment Computer Software And Accessories |
| 7/19/2017 |
DEN170022 |
Quantx |
Quantitative Insights, Inc |
Radiology |
Computer-Assisted Diagnostic Software For Lesions Suspicious For Cancer |
| 5/24/2018 |
DEN180005 |
OsteoDetect |
Imagen Technologies, Inc. |
Radiology |
Radiological Computer Assisted Detection/Diagnosis Software For Fracture |
| 3/26/2021 |
DEN200019 |
Oxehealth Vital Signs |
Oxehealth Limited |
Cardiovascular |
Software For Optical Camera-Based Measurement Of Pulse Rate, Heart Rate, Breathing Rate, And/Or Respiratory Rate |
| 3/1/2021 |
DEN200022 |
Analytic For Hemodynamic Instability (Ahi) |
Fifth Eye Inc. |
Cardiovascular |
Adjunctive Hemodynamic Indicator With Decision Point |
| 9/8/2021 |
DEN200030 |
FEops HEARTguide |
Feops NV |
Cardiovascular |
Interventional Cardiovascular Implant Simulation Software Device |
| 9/21/2021 |
DEN200080 |
Paige Prostate |
Paige.AI |
Pathology |
Software Algorithm Device To Assist Users In Digital Pathology |
| 2/17/2023 |
DEN210022 |
PMD-200 |
Medasense Biometrics Ltd. |
Anesthesiology |
Adjunctive Pain Measurement Device For Anesthesiology |
| 2/24/2023 |
DEN220063 |
Caption Interpretation Automated Ejection Fraction Software |
Caption Health, Inc |
Radiology |
Radiological Machine Learning Based Quantitative Imaging Software With Change Control Plan |
| 7/31/2001 |
K011582 |
QCU Analytical Software Package |
Medis Medical Imaging Systems, B.V. |
Radiology |
System, Image Processing, Radiological |
| 7/31/2001 |
K012211 |
eFilm Workstation |
Efilm Medical, Inc. |
Radiology |
System, Image Processing, Radiological |
| 1/8/2002 |
K014100 |
Opus Spectrum (A Model Of Opus 20), Model 2nd |
Opusdent Ltd. |
General & Plastic Surgery |
Powered Laser Surgical Instrument |
| 4/12/2002 |
K020995 |
eFilm Workstation with Modules |
Efilm Medical, Inc. |
Radiology |
System, Image Processing, Radiological |
| 7/12/2002 |
K021191 |
Autoalign |
Cortechs Labs, Inc. |
Radiology |
System, Image Processing, Radiological |
| 1/24/2003 |
K023970 |
Quantitative Vascular Angiography – CMS |
Medis Medical Imaging Systems, B.V. |
Radiology |
System, X-Ray, Angiographic |
| 8/11/2003 |
K031562 |
Ramsoft Pacs, Model 3.0 |
Ramsoft, Inc. |
Radiology |
System, Image Processing, Radiological |
| 8/25/2003 |
K032500 |
Modification To Wackers-Liu CQ Software |
Eclipse Systems, Inc. |
Radiology |
System, Tomography, Computed, Emission |
| 12/16/2004 |
K033266 |
Vascular Tools 5, Consisting Of Brachial Analyzer 5, Carotid Analyzer 5, Vascular Imager 5 and Integrated Vascular Tools |
Medical Imaging Applications LLC |
Cardiovascular |
Computer, Diagnostic, Programmable |
| 3/2/2004 |
K033774 |
CT-Mass |
Medis Medical Imaging Systems, B.V. |
Radiology |
System, X-Ray, Tomography, Computed |
| 2/2/2004 |
K033825 |
Orthopacs |
Etrauma.Com Corp. |
Radiology |
System, Image Processing, Radiological |
| 5/11/2004 |
K040688 |
Standard Imaging E.IMRT Calculator |
Standard Imaging, Inc. |
Radiology |
System, Planning, Radiation Therapy Treatment |
| 6/8/2004 |
K040746 |
MRA-CMS |
Medis Medical Imaging Systems, B.V. |
Radiology |
System, Image Processing, Radiological |
| 7/27/2004 |
K041162 |
Ortho-CMS |
Medis Medical Imaging Systems, B.V. |
Radiology |
System, Image Processing, Radiological |
| 6/22/2004 |
K041581 |
ComPACS, Version 1.0 |
Intelligent Images Srl |
Radiology |
System, Image Processing, Radiological |
| 10/20/2004 |
K042383 |
RSA-CMS |
Medis Medical Imaging Systems, B.V. |
Radiology |
System, Image Processing, Radiological |
| 11/15/2004 |
K042733 |
Standard Imaging PIPSpro QA Software System |
Standard Imaging, Inc. |
Radiology |
Instrument, Quality-Assurance, Radiologic |
| 12/15/2004 |
K043350 |
MIStar, Model V3.2 |
Apollo Medical Imaging Technology Pty Ltd. |
Radiology |
System, Image Processing, Radiological |
| 1/28/2005 |
K043483 |
RADIN, Model V 3.0 |
Sohard Ag |
Radiology |
System, Image Processing, Radiological |
| 8/24/2005 |
K050336 |
OPD-Station Software |
Nidek, Inc. |
Ophthalmic |
Aberrometer, Ophthalmic |
| 9/21/2005 |
K052411 |
Hipax Medical Imaging Software |
Steinhart Medizinsysteme Gmbh |
Radiology |
System, Image Processing, Radiological |
| 11/22/2005 |
K053010 |
VISTADENT AT COMPLETE, Model 3.1 |
Dentsply Intl., Inc. |
Radiology |
System, Image Processing, Radiological |
| 7/28/2006 |
K061368 |
Diagnosoft HARP |
Diagnosoft, Inc. |
Radiology |
System, Nuclear Magnetic Resonance Imaging |
| 10/27/2006 |
K062490 |
Visage PACS/CS, Release Version 4.1 |
Mercury Computer Systems, Inc |
Radiology |
System, Image Processing, Radiological |
| 1/24/2007 |
K063294 |
ToPACS |
Radiological Specialists, Inc. |
Radiology |
System, Image Processing, Radiological |
| 2/9/2007 |
K070244 |
Aegis |
Sentinelle Medical, Inc. |
Radiology |
System, Image Processing, Radiological |
| 3/1/2007 |
K070248 |
VelocityAIS |
Velocity Medical Solutions, LLC |
Radiology |
System, Image Processing, Radiological |
| 10/12/2007 |
K071713 |
Clarian Glucose Stabilizer Insulin Dosing Calculator |
Medical Decisions Network |
General Hospital |
Calculator, Drug Dose |
| 8/16/2007 |
K071894 |
Xebra DICOM Image Browser |
Hx Technologies, Inc. |
Radiology |
System, Image Processing, Radiological |
| 9/26/2007 |
K071964 |
MIM 4.1 (SEASTAR) |
Mimvista Corp. |
Radiology |
System, Image Processing, Radiological |
| 8/29/2007 |
K072205 |
Visage PACS/CS, Release Version 5.0 |
Mercury Computer Systems, Inc |
Radiology |
System, Image Processing, Radiological |
| 10/31/2008 |
K072752 |
bp Limbo XL, bp Tango XL, bp Salsa XL |
DataDancer Medical Systems |
Cardiovascular |
Computer, Diagnostic, Programmable |
| 2/14/2008 |
K073194 |
CMRtools and Plug-Ins Ventricular Tools & Thalassaemia Tools |
Cardiovascular Imaging Solutions Ltd. |
Radiology |
System, Image Processing, Radiological |
| 1/11/2008 |
K073630 |
Modification to: BPCard, Model Z-7000-0700 |
Qrs Diagnostic, LLC |
Cardiovascular |
System, Measurement, Blood-Pressure, Non-Invasive |
| 6/20/2008 |
K081076 |
VelocityAIS, Velocity AI, VelocityVX, VelocityRT, V-Response |
Velocity Medical Solutions, LLC |
Radiology |
System, Image Processing, Radiological |
| 6/9/2008 |
K081318 |
OneTouch Zoom Diabetes Management Program |
Lifescan, Inc. |
Clinical Chemistry |
System, Test, Blood Glucose, Over The Counter |
| 12/12/2008 |
K082269 |
Visage PACS, Version 6.0/CS 3.1 |
Visage Imaging, Inc. |
Radiology |
System, Image Processing, Radiological |
| 10/16/2008 |
K082402 |
OsDx Hip BMD System |
Imaging Therapeutics, Inc. |
Radiology |
Densitometer, Bone |
| 11/19/2008 |
K082773 |
Standard Imaging IMSure Brachy QA Software, Model 91331 |
Standard Imaging, Inc. |
Radiology |
Accelerator, Linear, Medical |
| 1/22/2009 |
K083264 |
RayAutoPlan 1.0 |
Raysearch Laboratories AB |
Radiology |
System, Planning, Radiation Therapy Treatment |
| 8/25/2009 |
K092004 |
GE Innova Solid State X-Ray-Imager Fluoroscopic X-Ray System, Model: 4100IQ, 3100IQ, 2100IQ |
GE Healthcare |
Radiology |
Interventional Fluoroscopic X-Ray System |
| 10/8/2009 |
K092204 |
PMD Viewer |
Spencer Technologies |
Radiology |
System, Image Processing, Radiological |
| 12/16/2009 |
K092928 |
Dose Volume Histogram (DVH) Evaluator |
Diversilabs, LLC |
Radiology |
System, Planning, Radiation Therapy Treatment |
| 4/28/2010 |
K093128 |
Illumina BeadXpress System |
Illumina, Inc. |
Hematology |
Instrumentation For Clinical Multiplex Test Systems |
| 3/11/2010 |
K100352 |
Diagnosoft HARP Model 2.06 |
Diagnosoft, Inc. |
Radiology |
System, Nuclear Magnetic Resonance Imaging |
| 4/1/2011 |
K100714 |
CSMC Cardiac Suite-Nuclear Medicine Software Application Model 2010-01 |
Cedars-Sinai Medical Center |
Radiology |
System, Tomography, Computed, Emission |
| 10/5/2010 |
K101324 |
GE EchoPac Model BT10 |
Ge Vingmed Ultrasound As |
Radiology |
System, Image Processing, Radiological |
| 10/29/2010 |
K101707 |
FulAccess Model 1.0 |
Fulcrum Medical, Inc |
Radiology |
System, Image Processing, Radiological |
| 1/5/2011 |
K103475 |
SpineAnalyer Model SAPOC |
Optasia Medical |
Radiology |
System, Image Processing, Radiological |
| 12/20/2011 |
K103554 |
Metron-CP/MD |
Eponatech LLC |
Radiology |
System, Image Processing, Radiological |
| 5/24/2012 |
K110644 |
Praezis Plus |
Tatramed Spol. S.R.O. |
Neurology |
Neurological Stereotaxic Instrument |
| 9/21/2012 |
K111142 |
EchoSoft(TM) |
Echometrix LLC |
Radiology |
System, Image Processing, Radiological |
| 7/28/2011 |
K111222 |
MRI-Q System |
Resonance Health Analysis Services Pty Ltd |
Radiology |
System, Image Processing, Radiological |
| 1/25/2012 |
K112251 |
Swissmeda Dental Planning System |
Swissmeda AG |
Radiology |
System, Image Processing, Radiological |
| 11/22/2011 |
K113027 |
syngo Aortic ValveGuide Software |
Siemens Medical Solutions Usa, Inc. |
Radiology |
Interventional Fluoroscopic X-Ray System |
| 1/30/2012 |
K113076 |
CAAS A-Valve |
Pie Medical Imaging B.V. |
Radiology |
System, Image Processing, Radiological |
| 9/13/2012 |
K113725 |
VirtuOst |
O.N. Diagnostics |
Radiology |
Densitometer, Bone |
| 4/17/2012 |
K120367 |
3mensio Workstation |
Pie Medical Imaging B.V. |
Radiology |
System, Image Processing, Radiological |
| 7/26/2012 |
K121075 |
NERVEVISION Software Systems |
3D Imaging Partners Inc. |
Radiology |
System, Image Processing, Radiological |
| 7/30/2012 |
K121292 |
DynaPBV Body Software |
Siemens Medical Solutions Usa, Inc. |
Radiology |
System, Image Processing, Radiological |
| 12/13/2013 |
K122035 |
HepaFat Scan |
Resonance Health Analysis Services Pty Ltd |
Radiology |
System, Nuclear Magnetic Resonance Imaging |
| 4/5/2013 |
K123089 |
Freestyle Auto-Assist Software Version 2.0 with Model PRT24238-001 |
Abbott Laboratories |
Clinical Chemistry |
System, Test, Blood Glucose, Over The Counter |
| 12/28/2012 |
K123357 |
OnQ rts |
Oncology Systems, Inc. |
Radiology |
System, Planning, Radiation Therapy Treatment |
| 2/6/2013 |
K123970 |
CAAS IntraVascular |
Pie Medical Imaging B.V. |
Radiology |
System, Image Processing, Radiological |
| 8/21/2013 |
K131158 |
CorView |
Marrek, Inc |
Radiology |
System, Image Processing, Radiological |
| 10/17/2013 |
K132636 |
DYONICS PLAN Hip Impingement Planning System |
Smith & Nephew, Inc. |
Radiology |
System, Image Processing, Radiological |
| 12/3/2013 |
K132742 |
M-Vu Breast Density |
Vucomp, Inc. |
Radiology |
System, Image Processing, Radiological |
| 12/16/2013 |
K133454 |
SonoSite Edge Ultrasound System |
Fujifilm Sonosite,Inc. |
Radiology |
System, Imaging, Pulsed Doppler, Ultrasonic |
| 6/5/2014 |
K140434 |
mediCAD Classic |
Hectec GmbH |
Radiology |
System, Image Processing, Radiological |
| 12/12/2014 |
K140797 |
IPACS Medical Image Management System |
Visbion Limited |
Radiology |
System, Image Processing, Radiological |
| 11/19/2014 |
K141462 |
Varia-NCI |
Neurochaos Solutions, Inc. |
Radiology |
System, Imaging, Pulsed Doppler, Ultrasonic |
| 7/31/2014 |
K141475 |
EndoSize |
Therenva Sas |
Radiology |
System, Image Processing, Radiological |
| 7/22/2014 |
K141652 |
Cedars-Sinai Cardiac Suite Nuclear Medicine Software |
Cedars-Sinai Medical Center |
Radiology |
System, Tomography, Computed, Emission |
| 9/17/2014 |
K142048 |
Emprint Procedure Planning Application |
Covidien LLC |
Radiology |
System, Image Processing, Radiological |
| 6/11/2015 |
K142512 |
Personalized Physiology Analytics Engine Software |
Vgbio, Inc. (DBA Physiq) |
Cardiovascular |
Multivariate Vital Signs Index |
| 2/6/2015 |
K143044 |
CAAS A-Valve |
Pie Medical Imaging B.V. |
Radiology |
System, Image Processing, Radiological |
| 4/2/2015 |
K143372 |
AWARE |
Ambient Clinical Analytics |
Cardiovascular |
Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms) |
| 1/12/2016 |
K151152 |
ImplantMax Software |
Saturn Imaging Inc. |
Radiology |
System, Image Processing, Radiological |
| 9/11/2015 |
K151560 |
QuickPlan |
Siris Medical |
Radiology |
System, Planning, Radiation Therapy Treatment |
| 8/19/2015 |
K151837 |
CS 3D Imaging |
Trophy |
Radiology |
System, Image Processing, Radiological |
| 9/16/2015 |
K151887 |
syngo VSim |
Siemens Medical Solutions Usa, Inc. |
Radiology |
System, Planning, Radiation Therapy Treatment |
| 1/13/2016 |
K152733 |
FFRct |
Heartflow, Inc. |
Cardiovascular |
Coronary Vascular Physiologic Simulation Software |
| 4/1/2016 |
K152881 |
Sentinel Cardiology Information Management System |
Spacelabs Healthcare Ltd. |
Cardiovascular |
Computer, Diagnostic, Programmable |
| 2/3/2016 |
K152994 |
Adaptivo |
Aurora Technology Development, LLC |
Radiology |
Accelerator, Linear, Medical |
| 4/12/2016 |
K160376 |
EndoSize |
Therenva Sas |
Radiology |
System, Image Processing, Radiological |
| 12/22/2016 |
K160949 |
Go Dose System |
Eli Lilly And Company |
General Hospital |
Calculator, Drug Dose |
| 8/24/2016 |
K161130 |
ResolutionMD |
Calgary Scientific, Inc. |
Radiology |
System, Image Processing, Radiological |
| 9/9/2016 |
K161201 |
ClearRead CT |
Riverain Technologies, LLC |
Radiology |
Lung Computed Tomography System, Computer-Aided Detection |
| 6/23/2016 |
K161559 |
Kuvia3D |
4Qimaging, LLC DBA Qmetrics |
Radiology |
System, Image Processing, Radiological |
| 8/24/2016 |
K161772 |
FFRct v2.0 |
Heartflow, Inc. |
Cardiovascular |
Coronary Vascular Physiologic Simulation Software |
| 10/6/2016 |
K161937 |
CuattroDR |
Cuattro, LLC |
Radiology |
System, X-Ray, Stationary |
| 8/18/2016 |
K162045 |
SonoSite SII Ultrasound System, SonoSite Edge II Ultrasound System |
Fujifilm Sonosite, Inc. |
Radiology |
System, Imaging, Pulsed Doppler, Ultrasonic |
| 12/8/2016 |
K162376 |
CAAS Mr 4D Flow |
Pie Medical Imaging B.V. |
Radiology |
System, Image Processing, Radiological |
| 1/12/2017 |
K162532 |
Welldoc BlueStar, Welldoc BlueStar Rx |
Welldoc, Inc |
General Hospital |
Accessories, Pump, Infusion |
| 3/31/2017 |
K162559 |
Move Forward 3D Motion Simulation Service |
Biomet Inc. |
Radiology |
System, Image Processing, Radiological |
| 3/31/2017 |
K162627 |
EnsoSleep |
Ensodata, Inc. |
Neurology |
Automatic Event Detection Software For Polysomnograph With Electroencephalograph |
| 12/26/2017 |
K170138 |
Neuronaute |
Bioserenity |
Neurology |
Full-Montage Standard Electroencephalograph |
| 9/12/2017 |
K170185 |
Tremoflo C-100 Airwave Oscillometry System |
Thorasys Thoracic Medical Systems, Inc. |
Anesthesiology |
Impedance Measuring Device Utilizing Oscillation Techniques |
| 2/23/2017 |
K170209 |
ImPACT |
ImPACT Applications, Inc. |
Neurology |
Computerized Cognitive Assessment Aid For Concussion |
| 6/21/2017 |
K170551 |
ImPACT Quick Test |
ImPACT Applications, Inc. |
Neurology |
Computerized Cognitive Assessment Aid For Concussion |
| 9/7/2018 |
K170702 |
mediCAD 4.0 |
MediCAD Hectec GmbH |
Radiology |
System, Image Processing, Radiological |
| 7/17/2017 |
K171115 |
3D Endo Software |
Dentsply Sirona |
Radiology |
System, Image Processing, Radiological |
| 1/11/2018 |
K171122 |
Cerec Ortho Software |
Dentsply Sirona |
Dental |
Orthodontic Software |
| 1/9/2018 |
K171295 |
ULab Systems Treatment Planning Software |
ULab Systems, Inc. |
Dental |
Orthodontic Software |
| 6/12/2017 |
K171437 |
Sonosite X-Porte Ultrasound System |
Fujifilm Sonosite, Inc. |
Radiology |
System, Imaging, Pulsed Doppler, Ultrasonic |
| 11/8/2017 |
K171534 |
SurgicalPreview |
Endo Vantage, LLC |
Cardiovascular |
Software For Visualization Of Vascular Anatomy And Intravascular Devices |
| 4/19/2018 |
K171720 |
Encevis |
Ait Austrian Institute Of Technology Gmbh |
Neurology |
Automatic Event Detection Software For Full-Montage Electroencephalograph |
| 9/21/2017 |
K171829 |
Endonaut |
Therenva Sas |
Radiology |
Interventional Fluoroscopic X-Ray System |
| 4/4/2018 |
K172239 |
Simplant 18 |
Dentsply Sirona |
Radiology |
System, Image Processing, Radiological |
| 10/27/2017 |
K172534 |
LINACwatch, LinacView |
Qualiformed Sarl |
Radiology |
Accelerator, Linear, Medical |
| 6/22/2018 |
K172586 |
Vios Monitoring System™ Model 2050 |
Vios Medical, Inc. |
Cardiovascular |
Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm) |
| 11/3/2017 |
K172609 |
CSMC Cardiac Suite |
Cedars-Sinai Medical Center |
Radiology |
System, Tomography, Computed, Emission |
| 4/5/2018 |
K172998 |
uWS-MI |
Shanghai United Imaging Healthcare Co.,Ltd. |
Radiology |
System, Image Processing, Radiological |
| 11/7/2018 |
K172999 |
uWS-MR |
Shanghai United Imaging Healthcare Co.,Ltd. |
Radiology |
System, Image Processing, Radiological |
| 11/7/2018 |
K173001 |
uWS-CT |
Shanghai United Imaging Healthcare Co.,Ltd. |
Radiology |
System, Image Processing, Radiological |
| 11/15/2017 |
K173329 |
jFit Surgical Planner |
JointVue LLC |
Radiology |
System, Image Processing, Radiological |
| 7/23/2018 |
K173444 |
Quantitative Total Extensible Imaging (QTxI) |
AIQ Solutions, Inc. |
Radiology |
System, Image Processing, Radiological |
| 7/14/2019 |
K173974 |
Drowzle |
Resonea, Inc. |
Anesthesiology |
Ventilatory Effort Recorder |
| 5/3/2018 |
K180019 |
CAAS Workstation |
Pie Medical Imaging BV |
Radiology |
System, X-Ray, Angiographic |
| 3/21/2018 |
K180192 |
Emprint Ablation Visualization Application |
Covidien, LLC |
Radiology |
System, Image Processing, Radiological |
| 8/16/2018 |
K180522 |
IGTFusion |
Igi Technologies |
Radiology |
System, Image Processing, Radiological |
| 11/26/2018 |
K181112 |
Orchestrate 3D |
Orchestrate 3D |
Dental |
Orthodontic Software |
| 10/20/2018 |
K181223 |
ImPACT |
ImPACT Applications, Inc. |
Neurology |
Computerized Cognitive Assessment Aid For Concussion |
| 7/10/2018 |
K181572 |
Workflow Box |
Mirada Medical Ltd. |
Radiology |
Radiological Image Processing Software For Radiation Therapy |
| 11/21/2018 |
K181704 |
Transpara |
Screenpoint Medical Bv |
Radiology |
Radiological Computer Assisted Detection/Diagnosis Software For Lesions Suspicious For Cancer |
| 3/11/2019 |
K181823 |
KardiaAI |
Alivecor, Inc. |
Cardiovascular |
Computer, Diagnostic, Programmable |
| 12/4/2018 |
K181825 |
CAAS Mr Solutions |
Pie Medical Imaging B.V. |
Radiology |
System, Image Processing, Radiological |
| 3/1/2019 |
K181932 |
DTX Studio design |
Nobel Biocare AB |
Dental |
Dental Abutment Design Software For Dental Laboratory |
| 12/6/2018 |
K182035 |
FFRct v2.18 |
Heartflow, Inc. |
Cardiovascular |
Coronary Vascular Physiologic Simulation Software |
| 1/28/2019 |
K182093 |
Zoll ECG Analysis Software |
Zoll Manufacturing Corporation |
Cardiovascular |
Electrocardiograph |
| 12/19/2018 |
K182149 |
FFRangio System |
Cathworks Ltd |
Cardiovascular |
Angiographic Coronary Vascular Physiologic Simulation Software |
| 11/30/2018 |
K182218 |
Ferrismart Analysis System |
Resonance Health Analysis Services Pty Ltd |
Radiology |
Liver Iron Concentration Imaging Companion Diagnostic For Deferasirox |
| 12/13/2018 |
K182359 |
Hipcheck |
Stryker Corp. |
Radiology |
System, Image Processing, Radiological |
| 12/6/2018 |
K182373 |
Powerlook Tomo Detection V2 Software |
Icad Inc. |
Radiology |
Radiological Computer Assisted Detection/Diagnosis Software For Lesions Suspicious For Cancer |
| 8/14/2019 |
K182618 |
Sleepimage System |
Mycardio, LLC DBA Sleepimage |
Anesthesiology |
Ventilatory Effort Recorder |
| 2/14/2019 |
K182756 |
Myostrain 5.1 |
Myocardial Solutions |
Radiology |
System, Nuclear Magnetic Resonance Imaging |
| 3/22/2019 |
K183164 |
uWS-MR |
Shanghai United Imaging Healthcare Co., Ltd. |
Radiology |
System, Image Processing, Radiological |
| 6/24/2019 |
K183170 |
uWS-CT |
Shanghai United Imaging Healthcare Co., Ltd. |
Radiology |
System, Image Processing, Radiological |
| 8/15/2019 |
K183282 |
Biovitals Analytics Engine |
Biofourmis Singapore Pte. Ltd |
Cardiovascular |
Multivariate Vital Signs Index |
| 10/3/2019 |
K183479 |
Asthma Monitor AM3 |
eResearchTechnology |
Anesthesiology |
Spirometer, Diagnostic |
| 11/4/2019 |
K190013 |
Welldoc BlueStar |
Welldoc, Inc. |
General Hospital |
Accessories, Pump, Infusion |
| 7/3/2019 |
K190442 |
Koios DS For Breast |
Koios Medical, Inc. |
Radiology |
Computer-Assisted Diagnostic Software For Lesions Suspicious For Cancer |
| 8/15/2019 |
K190925 |
HeartfFow FFRct Analysis |
Heartflow, Inc. |
Cardiovascular |
Coronary Vascular Physiologic Simulation Software |
| 11/27/2019 |
K190955 |
Hypotension Decision Assist |
Directed Systems Ltd |
Cardiovascular |
Computer, Diagnostic, Pre-Programmed, Single-Function |
| 11/7/2019 |
K191026 |
Medip Pro |
Medicalip Co., Ltd |
Radiology |
System, Image Processing, Radiological |
| 11/13/2019 |
K191171 |
Echogo Core |
Ultromics Ltd. |
Radiology |
Automated Radiological Image Processing Software |
| 1/24/2020 |
K191406 |
KardiaMobile, KardiaStation |
Alivecor, Inc. |
Cardiovascular |
Transmitters And Receivers, Electrocardiograph, Telephone |
| 9/26/2019 |
K191530 |
Stonechecker |
Imaging Biometrics, LLC |
Radiology |
System, Image Processing, Radiological |
| 3/4/2020 |
K191550 |
Broncholab |
Fluidda Inc. |
Radiology |
System, X-Ray, Tomography, Computed |
| 10/1/2019 |
K191610 |
RTapp |
Segana, LLC |
Radiology |
System, Image Processing, Radiological |
| 12/20/2019 |
K191647 |
Qlab Advanced Quantification Software |
Philips Healthcare |
Radiology |
Automated Radiological Image Processing Software |
| 9/16/2019 |
K191688 |
SubtleMR |
Subtle Medical, Inc. |
Radiology |
System, Image Processing, Radiological |
| 3/23/2020 |
K191716 |
Somryst |
Pear Therapeutics, Inc. |
Neurology |
Computerized Behavioral Therapy Device For Insomnia |
| 4/17/2020 |
K191720 |
BRUIS Software Suite |
Mechanodontics, Inc. |
Dental |
Orthodontic Software |
| 2/28/2020 |
K191928 |
AccuContour |
Xiamen Manteia Technology Ltd. |
Radiology |
Radiological Image Processing Software For Radiation Therapy |
| 10/4/2019 |
K191994 |
Profound AI Software V2.1 |
Icad Inc. |
Radiology |
Radiological Computer Assisted Detection/Diagnosis Software For Lesions Suspicious For Cancer |
| 12/2/2019 |
K192038 |
Emprint Visualization Application |
Covidien LLC. |
Radiology |
System, Image Processing, Radiological |
| 4/13/2020 |
K192167 |
Curarad-ICH |
Curacloud Corp. |
Radiology |
Radiological Computer-Assisted Triage And Notification Software |
| 12/10/2019 |
K192287 |
Transpara |
Screenpoint Medical B.V. |
Radiology |
Radiological Computer Assisted Detection/Diagnosis Software For Lesions Suspicious For Cancer |
| 2/10/2020 |
K192377 |
Ethos Treatment Management, Ethos Treatment Planning, Ethos Radiotherapy System, Halcyon |
Varian Medical Systems, Inc. |
Radiology |
Accelerator, Linear, Medical |
| 3/25/2020 |
K192437 |
Arterys MICA |
Arterys Inc. |
Radiology |
Automated Radiological Image Processing Software |
| 12/9/2019 |
K192442 |
FFRangio |
Cathworks Ltd |
Cardiovascular |
Angiographic Coronary Vascular Physiologic Simulation Software |
| 6/1/2020 |
K192601 |
uWS-MR |
Shanghai United Imaging Healthcare Co., Ltd |
Radiology |
Automated Radiological Image Processing Software |
| 6/11/2020 |
K192630 |
uWS-MI |
Shanghai United Imaging Healthcare Co., Ltd. |
Radiology |
System, Image Processing, Radiological |
| 5/28/2020 |
K192692 |
Brainomix 360 E-CTA |
Brainomix Limited |
Radiology |
System, Image Processing, Radiological |
| 4/21/2020 |
K192701 |
Dibs (Digital Indirect Bonding System) |
Orthoselect, LLC |
Dental |
Orthodontic Software |
| 12/13/2019 |
K192829 |
Demetra BDEM-01 Dermatoscope |
Barco Nv |
General & Plastic Surgery |
Light Based Imaging |
| 7/21/2020 |
K192847 |
Autolign |
Diorco Co., Ltd. |
Dental |
Orthodontic Software |
| 3/25/2020 |
K192854 |
Mammoscreen |
Therapixel |
Radiology |
Radiological Computer Assisted Detection/Diagnosis Software For Lesions Suspicious For Cancer |
| 7/2/2020 |
K192880 |
Inferread Lung CT.AI |
Beijing Infervision Technology Co.,Ltd. |
Radiology |
Lung Computed Tomography System, Computer-Aided Detection |
| 7/10/2020 |
K192969 |
Ezra Plexo Software |
Ezra Ai Inc. |
Radiology |
Automated Radiological Image Processing Software |
| 8/26/2020 |
K193177 |
CER-S |
Cardiocalm |
Cardiovascular |
Electrocardiograph, Ambulatory, With Analysis Algorithm |
| 3/9/2020 |
K193216 |
Syngo.Ct Lung Cad |
Siemens Medical Solutions, Inc |
Radiology |
Lung Computed Tomography System, Computer-Aided Detection |
| 3/5/2020 |
K193229 |
Transpara |
Screenpoint Medical B.V. |
Radiology |
Radiological Computer Assisted Detection/Diagnosis Software For Lesions Suspicious For Cancer |
| 7/2/2020 |
K193252 |
Contour ProtegeAI |
Mim Software, Inc. |
Radiology |
Radiological Image Processing Software For Radiation Therapy |
| 7/30/2020 |
K193283 |
AI-Rad Companion Prostate MR |
Siemens Medical Solutions Usa Inc |
Radiology |
Automated Radiological Image Processing Software |
| 6/21/2021 |
K193301 |
Codiagnostix |
Dental Wings GmbH |
Dental |
Driver, Wire, And Bone Drill, Manual |
| 2/18/2021 |
K193330 |
Clue Birth Control |
Biowink GmbH |
Obstetrics/Gynecology |
Device, Fertility Diagnostic, Contraceptive, Software Application |
| 7/30/2020 |
K193417 |
Fracturedetect (Fx) |
Imagen Technologies, Inc. |
Radiology |
Radiological Computer Assisted Detection/Diagnosis Software For Fracture |
| 10/30/2020 |
K193421 |
Smart Alarm Interface |
Boxview, LLC |
Cardiovascular |
System, Network And Communication, Physiological Monitors |
| 11/6/2020 |
K193562 |
AI-Rad Companion Organs Rt |
Siemens Medical Solutions Usa, Inc. |
Radiology |
Radiological Image Processing Software For Radiation Therapy |
| 10/9/2020 |
K193631 |
Stethee Pro 1, Stethee Pro Software System |
M3Dicine Pty Ltd. |
Cardiovascular |
Stethoscope, Electronic |
| 4/7/2020 |
K193654 |
Bluestar Rx |
Welldoc, Inc |
Clinical Chemistry |
Accessories, Pump, Infusion |
| 6/23/2020 |
K200232 |
Lvivo Software Application |
Dia Imaging Analysis Ltd |
Radiology |
Automated Radiological Image Processing Software |
| 10/30/2020 |
K200323 |
Autocontour |
Radformation, Inc. |
Radiology |
Radiological Image Processing Software For Radiation Therapy |
| 6/11/2020 |
K200356 |
MEDO ARIA |
Medo.Ai |
Radiology |
Automated Radiological Image Processing Software |
| 4/1/2020 |
K200524 |
SOMATOM X.cite, Scan&GO, SOMATOM go.Platform – go.Up, go.Now, go.Top, go.All, go. Sim, go. Open Pro, Scan&GO |
Siemens Medical Solutions Usa, Inc. |
Radiology |
System, X-Ray, Tomography, Computed |
| 7/22/2020 |
K200621 |
Caption Interpretation Automated Ejection Fraction Software |
Caption Health |
Radiology |
Automated Radiological Image Processing Software |
| 6/26/2020 |
K200760 |
Rapid Aspects |
ISchemaView Inc. |
Radiology |
Computer-Assisted Diagnostic Software For Lesions Suspicious For Cancer |
| 6/23/2020 |
K200772 |
Ulab Systems Udesign Software |
Ulab Systems, Inc. |
Dental |
Orthodontic Software |
| 6/15/2020 |
K200899 |
Quantib AI Node |
Quantib BV |
Radiology |
System, Image Processing, Radiological |
| 7/9/2020 |
K200941 |
Rapid LVO |
iSchemaView Inc. |
Radiology |
Radiological Computer-Assisted Triage And Notification Software |
| 6/3/2020 |
K200974 |
Qlab Advanced Quantification Software |
Philips Healthcare |
Radiology |
Automated Radiological Image Processing Software |
| 11/18/2020 |
K201019 |
Genius Ai Detection |
Hologic, Inc. |
Radiology |
Radiological Computer Assisted Detection/Diagnosis Software For Lesions Suspicious For Cancer |
| 12/22/2020 |
K201036 |
Planimax Orthodontic Software |
Choice Biotech Inc. |
Dental |
Orthodontic Software |
| 12/7/2020 |
K201039 |
HepaFat-AI |
Resonance Health Analysis Services Pty Ltd |
Radiology |
System, Nuclear Magnetic Resonance Imaging |
| 8/4/2020 |
K201168 |
ECG Monitor App |
Samsung Electronics Co., Ltd |
Cardiovascular |
Electrocardiograph Software For Over-The-Counter Use |
| 9/23/2020 |
K201208 |
Halo AF Detection System |
Livmor |
Cardiovascular |
Transmitters And Receivers, Electrocardiograph, Telephone |
| 8/13/2020 |
K201232 |
Limbus Contour |
Limbus Ai Inc. |
Radiology |
System, Image Processing, Radiological |
| 1/29/2021 |
K201411 |
Visage Breast Density |
Visage Imaging GmbH |
Radiology |
Automated Radiological Image Processing Software |
| 9/25/2020 |
K201439 |
Ventilator, Non-Continuous (Respirator) |
Respironics, Inc. |
Anesthesiology |
Ventilator, Non-Continuous (Respirator) |
| 12/18/2020 |
K201555 |
EchoGo Pro |
Ultromics Ltd. |
Radiology |
Computer-Assisted Diagnostic Software For Lesions Suspicious For Cancer |
| 7/8/2021 |
K201835 |
Pre-Sure |
Lazarus, 3D, Inc |
Radiology |
System, Image Processing, Radiological |
| 11/13/2020 |
K201881 |
Coroflow Cardiovascular System |
Coroventis Research Ab |
Cardiovascular |
Computer, Diagnostic, Programmable |
| 11/12/2020 |
K201985 |
KardiaAI |
Alivecor, Inc. |
Cardiovascular |
Computer, Diagnostic, Programmable |
| 10/30/2020 |
K202013 |
WRDensity by Whiterabbit.ai |
Whiterabbit.Ai Inc. |
Radiology |
Automated Radiological Image Processing Software |
| 2/19/2021 |
K202212 |
Truplan |
Circle Cardiovascular Imaging Inc. |
Radiology |
System, Image Processing, Radiological |
| 9/9/2020 |
K202256 |
3Shape Implant Studio |
3Shape Medical A/S |
Radiology |
System, Image Processing, Radiological |
| 3/5/2021 |
K202300 |
Optellum Virtual Nodule Clinic, Optellum Software, Optellum Platform |
Optellum Ltd |
Radiology |
Computer-Assisted Diagnostic Software For Lesions Suspicious For Cancer |
| 12/22/2021 |
K202404 |
BoneMRI |
MRIguidance B.V |
Radiology |
Automated Radiological Image Processing Software |
| 12/25/2020 |
K202485 |
ImPACT Version 4 |
ImPACT Applications, Inc. |
Neurology |
Computerized Cognitive Assessment Aid For Concussion |
| 10/30/2020 |
K202497 |
Aulisa Multiple Patient Digital Vital Sign Monitoring System |
Taiwan Aulisa Medical Devices Technologies, Inc. |
Cardiovascular |
System, Network And Communication, Physiological Monitors |
| 9/29/2020 |
K202546 |
LVivo Seamless |
Dia Imaging Analysis Ltd. |
Radiology |
Automated Radiological Image Processing Software |
| 1/14/2021 |
K202700 |
Art-Plan |
Therapanacea |
Radiology |
Radiological Image Processing Software For Radiation Therapy |
| 6/24/2021 |
K202897 |
Natural Cycles |
Natural Cycles Nordic AB |
Obstetrics/Gynecology |
Device, Fertility Diagnostic, Contraceptive, Software Application |
| 4/2/2021 |
K202928 |
DV.Target |
Deepvoxel, Inc. |
Radiology |
Radiological Image Processing Software For Radiation Therapy |
| 8/31/2021 |
K203084 |
Ablamap Software |
Ablacon, Inc. |
Cardiovascular |
Computer, Diagnostic, Programmable |
| 1/15/2021 |
K203142 |
Veuron-Brain-Pab |
Heuron Co., Ltd. |
Radiology |
System, Image Processing, Radiological |
| 2/26/2021 |
K203182 |
SubtleMR |
Subtle Medical, Inc. |
Radiology |
System, Image Processing, Radiological |
| 3/19/2021 |
K203235 |
Vbrain |
Vysioneer Inc. |
Radiology |
Radiological Image Processing Software For Radiation Therapy |
| 3/9/2021 |
K203256 |
Imbio RV/LV Software |
Imbio, LLC |
Radiology |
Automated Radiological Image Processing Software |
| 3/31/2021 |
K203258 |
syngo.CT Lung CAD (Version VD20) |
Siemens Healthcare GmbH |
Radiology |
Lung Computed Tomography System, Computer-Aided Detection |
| 1/8/2021 |
K203329 |
Heartflow Analysis |
Heartflow, Inc. |
Cardiovascular |
Coronary Vascular Physiologic Simulation Software |
| 9/8/2021 |
K203434 |
BlueStar Rx |
Welldoc, Inc |
Clinical Chemistry |
Calculator, Drug Dose |
| 8/20/2021 |
K203486 |
Otoplan |
Cascination Ag |
Ear Nose & Throat |
Image Management Software For Planning Of Otologic And Neurotologic Procedures |
| 4/23/2021 |
K203502 |
MEDO-Thyroid |
Medo Dx Pte. Ltd. |
Radiology |
Automated Radiological Image Processing Software |
| 9/8/2021 |
K203555 |
AmCAD-UT |
Amcad Biomed Corporation |
Radiology |
Automated Radiological Image Processing Software |
| 9/7/2022 |
K203594 |
EyeCTester |
Neuro-Eye Diagnostic Systems LLC |
Ophthalmic |
Digital Amsler Grid |
| 4/20/2021 |
K203610 |
Automatic Anatomy Recognition (AAR) |
Quantitative Radiology Solutions, LLC |
Radiology |
Radiological Image Processing Software For Radiation Therapy |
| 2/26/2021 |
K203651 |
Cuptimize |
Cuptimize, Inc. |
Radiology |
System, Image Processing, Radiological |
| 1/23/2023 |
K203689 |
Tidepool Loop |
Tidepool Project |
Clinical Chemistry |
Interoperable Automated Glycemic Controller |
| 8/27/2021 |
K203696 |
Rbknee |
Radiobotics Aps |
Radiology |
System, Image Processing, Radiological |
| 3/14/2022 |
K203744 |
Arterys MICA |
Arterys Inc. |
Radiology |
Automated Radiological Image Processing Software |
| 9/10/2021 |
K203785 |
ClariSIGMAM |
Claripi Inc. |
Radiology |
Automated Radiological Image Processing Software |
| 3/12/2021 |
K203822 |
Profound AI Software V3.0 |
Icad Inc. |
Radiology |
Radiological Computer Assisted Detection/Diagnosis Software For Lesions Suspicious For Cancer |
| 2/5/2021 |
K210053 |
LVivo Software Application |
Dia Imaging Analysis Ltd. |
Radiology |
Automated Radiological Image Processing Software |
| 9/10/2021 |
K210093 |
AccuFFRangio |
Arteryflow Technology Co., Ltd. |
Radiology |
X-Ray Angiographic Imaging Based Coronary Vascular Simulation Software Device |
| 12/3/2021 |
K210241 |
Implastation |
Prodigident, Inc. |
Radiology |
System, Image Processing, Radiological |
| 6/2/2021 |
K210404 |
Transpara 1.7.0 |
Screenpoint Medical B.V. |
Radiology |
Radiological Computer Assisted Detection/Diagnosis Software For Lesions Suspicious For Cancer |
| 6/11/2021 |
K210484 |
LINQ II Insertable Cardiac Monitor, Zelda AI ECG Classification System |
Medtronic, Inc. |
Cardiovascular |
Recorder, Event, Implantable Cardiac, (With Arrhythmia Detection) |
| 4/21/2021 |
K210556 |
Preview Shoulder |
Genesis Software Innovations |
Radiology |
Automated Radiological Image Processing Software |
| 10/20/2021 |
K210632 |
Contour ProtegeAI |
Mim Software Inc. |
Radiology |
Radiological Image Processing Software For Radiation Therapy |
| 12/21/2021 |
K210670 |
BU-CAD |
Taihao Medical Inc. |
Radiology |
Radiological Computer Assisted Detection/Diagnosis Software For Lesions Suspicious For Cancer |
| 7/20/2021 |
K210719 |
Change Healthcare Anatomical Ai |
Change Healthcare Canada Company |
Radiology |
Automated Radiological Image Processing Software |
| 1/19/2022 |
K210747 |
Caption Interpretation Automated Ejection Fraction Software |
Caption Health |
Radiology |
Automated Radiological Image Processing Software |
| 1/14/2022 |
K210760 |
Precise Image |
Philips Medical Systems Nederland, B.V. |
Radiology |
System, X-Ray, Tomography, Computed |
| 7/27/2021 |
K210791 |
Us2.V1 |
Eko.Ai Pte. Ltd. D/B/A Us2.Ai |
Radiology |
Automated Radiological Image Processing Software |
| 11/19/2021 |
K210831 |
ONQ Neuro |
Cortechs Labs, Inc. |
Radiology |
Automated Radiological Image Processing Software |
| 10/14/2021 |
K210999 |
SwiftMR |
Airs Medical Inc. |
Radiology |
System, Image Processing, Radiological |
| 6/3/2022 |
K211046 |
eCareManager 4.5 |
Visicu, Inc. |
Cardiovascular |
System, Network And Communication, Physiological Monitors |
| 10/29/2021 |
K211161 |
Critical Care Suite With Endotracheal Tube Positing Ai Algorithm |
Ge Medical Systems, LLC |
Radiology |
Automated Radiological Image Processing Software |
| 7/30/2021 |
K211222 |
qER-Quant |
Qure.Ai Technologies |
Radiology |
Automated Radiological Image Processing Software |
| 9/10/2021 |
K211257 |
EFAI PACS Picture Archiving and Communication System |
Ever Fortune.Ai Co., Ltd. |
Radiology |
System, Image Processing, Radiological |
| 11/19/2021 |
K211326 |
EndoScreener |
Chengdu Wision Medical Device Co., Ltd. |
Gastroenterology/Urology |
Gastrointestinal Lesion Software Detection System |
| 8/2/2021 |
K211431 |
Breastscape V1.0 |
Olea Medical |
Radiology |
Automated Radiological Image Processing Software |
| 11/23/2021 |
K211432 |
Myomics Q |
Phantomics Inc. |
Radiology |
System, Image Processing, Radiological |
| 12/2/2021 |
K211452 |
Encevis |
Austrian Institute Of Technology GmbH |
Neurology |
Automatic Event Detection Software For Full-Montage Electroencephalograph |
| 6/10/2021 |
K211459 |
Syngo.Via Mi Workflows, Scenium, Syngo Mbf |
Siemens Medical Solutions Usa, Inc. |
Radiology |
Automated Radiological Image Processing Software |
| 11/24/2021 |
K211463 |
Regulora |
Metame Health, Inc. |
Gastroenterology/Urology |
Computerized Behavioral Therapy Device For Treating Symptoms |
| 7/12/2021 |
K211506 |
Powerlook Density Assessment Software V4.0 |
Icad Inc. |
Radiology |
Automated Radiological Image Processing Software |
| 11/26/2021 |
K211541 |
Mammoscreen 2.0 |
Therapixel |
Radiology |
Radiological Computer Assisted Detection/Diagnosis Software For Lesions Suspicious For Cancer |
| 9/30/2021 |
K211591 |
Naeotom Alpha, Scan&Go |
Siemens Medical Solutions Usa, Inc. |
Radiology |
System, X-Ray, Tomography, Computed |
| 9/30/2022 |
K211611 |
QIR Suite |
Casis Cardiac Simulation & Imaging Software |
Radiology |
Automated Radiological Image Processing Software |
| 11/17/2021 |
K211678 |
Lunit Insight Mmg |
Lunit Inc. |
Radiology |
Radiological Computer Assisted Detection/Diagnosis Software For Lesions Suspicious For Cancer |
| 8/25/2022 |
K211841 |
MRI Planner |
Spectronic Medical AB |
Radiology |
System, Planning, Radiation Therapy Treatment |
| 11/12/2021 |
K211876 |
Intellijoint View |
Intellijoint Surgical Inc. |
Radiology |
System, Image Processing, Radiological |
| 1/12/2022 |
K212005 |
Unid Spine Analyzer |
Medicrea International, Inc. |
Radiology |
System, Image Processing, Radiological |
| 1/19/2022 |
K212012 |
Follicle Clarity |
Cycle Clarity |
Radiology |
Automated Radiological Image Processing Software |
| 3/11/2022 |
K212040 |
RI.Hip Modeler |
Blue Belt Technologies, Inc. |
Radiology |
System, Image Processing, Radiological |
| 10/12/2021 |
K212116 |
Vbrain-Oar |
Vysioneer Inc. |
Radiology |
Radiological Image Processing Software For Radiation Therapy |
| 10/25/2021 |
K212218 |
Advanced Algorithms For Treatment Management Applications (Aatma) |
Elekta Solutions Ab |
Radiology |
Radiological Image Processing Software For Radiation Therapy |
| 9/23/2021 |
K212321 |
JiveX (Model Number / Release: 5.3) |
Visus Health It GmbH |
Radiology |
System, Image Processing, Radiological |
| 3/1/2022 |
K212365 |
Boneview |
Gleamer |
Radiology |
Radiological Computer Assisted Detection/Diagnosis Software For Fracture |
| 4/8/2022 |
K212372 |
Fitbit Irregular Rhythm Notifications |
Fitbit Inc |
Cardiovascular |
Photoplethysmograph Analysis Software For Over-The-Counter Use |
| 9/3/2021 |
K212421 |
ADAS 3D |
Adas3D Medical S.L |
Radiology |
System, Image Processing, Radiological |
| 12/9/2021 |
K212466 |
LVivo Seamless V2.0 |
Dia Imaging Analysis Ltd |
Radiology |
Automated Radiological Image Processing Software |
| 10/20/2021 |
K212470 |
iRAD |
Claritas Healthtech Pte Ltd |
Radiology |
System, Image Processing, Radiological |
| 10/22/2021 |
K212516 |
IRNF App |
Apple Inc. |
Cardiovascular |
Photoplethysmograph Analysis Software For Over-The-Counter Use |
| 11/23/2021 |
K212529 |
Hypotension Decision Assist Model Hda-Or2 |
Directed Systems Ltd |
Cardiovascular |
Computer, Diagnostic, Pre-Programmed, Single-Function |
| 11/8/2021 |
K212550 |
Hura CTP v1.0 |
Hura Imaging, Inc. |
Radiology |
System, Image Processing, Radiological |
| 2/22/2023 |
K212587 |
3D-RD-S |
Radiopharmaceutical Imaging And Dosimetry, LLC |
Radiology |
Camera, Scintillation (Gamma) |
| 12/16/2021 |
K212616 |
Koios DS |
Koios Medical, Inc. |
Radiology |
Computer-Assisted Diagnostic Software For Lesions Suspicious For Cancer |
| 2/11/2022 |
K212622 |
Zyter RPM |
Zyter, Inc. |
Cardiovascular |
System, Network And Communication, Physiological Monitors |
| 4/4/2022 |
K212624 |
EFAI Intelligent Cardiothoracic Ratio (iCTR) Assessment System |
Ever Fortune. Ai Co., Ltd. |
Radiology |
Automated Radiological Image Processing Software |
| 2/4/2022 |
K212654 |
Micro C Medical Imaging System, M01 |
Oxos Medical, Inc. |
Radiology |
System, X-Ray, Mobile |
| 4/26/2022 |
K212662 |
Alivecor QT Service |
Alivecor, Inc. |
Cardiovascular |
Computer, Diagnostic, Programmable |
| 12/21/2021 |
K212690 |
qXR-BT |
Qure.Ai Technologies |
Radiology |
Automated Radiological Image Processing Software |
| 5/19/2023 |
K212758 |
Autoplaque |
Cedars-Sinai Medical Center: Aim |
Radiology |
System, Image Processing, Radiological |
| 7/8/2022 |
K212783 |
Prostatid |
Scanmed, LLC |
Radiology |
Radiological Computer Assisted Detection/Diagnosis Software For Lesions Suspicious For Cancer |
| 10/1/2021 |
K212828 |
Brius Planner Software |
Brius Technologies Inc |
Dental |
Orthodontic Software |
| 11/10/2021 |
K212887 |
RTapp |
Segana, Inc. |
Radiology |
System, Image Processing, Radiological |
| 5/3/2022 |
K212915 |
MVision AI Segmentation |
MVision AI |
Radiology |
Radiological Image Processing Software For Radiation Therapy |
| 10/21/2022 |
K213128 |
Intraop Vsp Software Device |
Xironetic, LLC |
Radiology |
System, Image Processing, Radiological |
| 12/22/2021 |
K213140 |
Claritas Ipet |
Claritas Healthtech Pte Ltd |
Radiology |
System, Image Processing, Radiological |
| 12/15/2021 |
K213155 |
Rt-Mind-AI |
Medmind Technology Co., Ltd. |
Radiology |
Radiological Image Processing Software For Radiation Therapy |
| 2/8/2022 |
K213165 |
Rapid |
Ischema View Inc. |
Radiology |
System, Image Processing, Radiological |
| 6/22/2022 |
K213230 |
T3 Platform Software |
Etiometry, Inc. |
Cardiovascular |
Adjunctive Cardiovascular Status Indicator |
| 3/31/2023 |
K213272 |
Formus Hip |
Formus Labs, Ltd |
Radiology |
Automated Radiological Image Processing Software |
| 12/20/2021 |
K213275 |
Echogo Core (2.0) |
Ultromics Limited |
Radiology |
Automated Radiological Image Processing Software |
| 1/14/2022 |
K213307 |
Eclipse Ii With Smart Noise Cancellation |
Carestream Health, Inc. |
Radiology |
Solid State X-Ray Imager (Flat Panel/Digital Imager) |
| 7/19/2022 |
K213409 |
Zeus System (Zio Watch) |
Irhythm Technologies, Inc. |
Cardiovascular |
Computer, Diagnostic, Programmable |
| 1/6/2023 |
K213423 |
T3 Platform Software |
Etiometry. Inc. |
Cardiovascular |
Multivariate Vital Signs Index |
| 1/6/2022 |
K213544 |
Tomtec-Arena |
Tomtec Imaging Systems GmbH |
Radiology |
Automated Radiological Image Processing Software |
| 12/16/2021 |
K213628 |
Vbrain |
Vysioneer Inc. |
Radiology |
Radiological Image Processing Software For Radiation Therapy |
| 8/8/2022 |
K213645 |
Clearpoint Maestro Brain Model |
Clearpoint Neuro, Inc. |
Radiology |
Automated Radiological Image Processing Software |
| 4/1/2022 |
K213657 |
Deepvessel Ffr |
Keyamed Na Inc. |
Cardiovascular |
Coronary Vascular Physiologic Simulation Software |
| 4/15/2022 |
K213706 |
AI-Rad Companion Brain MR |
Siemens Healthcare GmbH |
Radiology |
Automated Radiological Image Processing Software |
| 5/31/2022 |
K213731 |
Efai Cardiosuite Spect Myocardial Perfusion Agile Workflows |
Ever Fortune.Ai Co., Ltd. |
Radiology |
System, Tomography, Computed, Emission |
| 3/16/2022 |
K213779 |
Customize |
3D-Side SA |
Radiology |
Automated Radiological Image Processing Software |
| 2/4/2022 |
K213801 |
Veuron-Brain-Pab2 |
Heuron Co., Ltd. |
Radiology |
System, Image Processing, Radiological |
| 10/14/2022 |
K213857 |
Heartflow Analysis |
Heartflow, Inc. |
Cardiovascular |
Coronary Vascular Physiologic Simulation Software |
| 4/25/2022 |
K213861 |
CER-S |
Cardiocalm Srl |
Cardiovascular |
Computer, Diagnostic, Programmable |
| 12/16/2021 |
K213916 |
Archform Orthodontic Software System |
Archform, Inc |
Dental |
Orthodontic Software |
| 3/11/2022 |
K213957 |
Demetra Dermatoscope BDEM-01 |
Barco Nv |
General & Plastic Surgery |
Light Based Imaging |
| 6/3/2022 |
K213971 |
Atrial Fibrillation History Feature |
Apple Inc. |
Cardiovascular |
Photoplethysmograph Analysis Software For Over-The-Counter Use |
| 2/3/2022 |
K213976 |
Contour ProtegeAI |
Mim Software Inc. |
Radiology |
Radiological Image Processing Software For Radiation Therapy |
| 4/13/2023 |
K213986 |
Cerebralgo Plus |
Yukun (Beijing) Technology Co., Ltd |
Radiology |
Automated Radiological Image Processing Software |
| 7/28/2022 |
K213998 |
Cvi42 Auto Imaging Software Application |
Circle Cardiovascular Imaging Inc |
Radiology |
Automated Radiological Image Processing Software |
| 12/23/2022 |
K214036 |
Aview |
Coreline Soft Co.,Ltd. |
Radiology |
Automated Radiological Image Processing Software |
| 9/29/2022 |
K220080 |
Cognet Qmtriage |
Medcognetics, Inc. |
Radiology |
Radiological Computer-Assisted Prioritization Software For Lesions |
| 5/12/2022 |
K220105 |
Saige-Dx |
Deephealth, Inc. |
Radiology |
Radiological Computer Assisted Detection/Diagnosis Software For Lesions Suspicious For Cancer |
| 6/2/2022 |
K220164 |
Rayvolve |
Azmed Sas |
Radiology |
Radiological Computer Assisted Detection/Diagnosis Software For Fracture |
| 4/28/2022 |
K220264 |
Efai RTsuite Ct Hn-Segmentation System |
Ever Fortune.Ai Co., Ltd. |
Radiology |
Radiological Image Processing Software For Radiation Therapy |
| 6/24/2022 |
K220300 |
Otoplan |
Cascination Ag |
Ear Nose & Throat |
Image Management Software For Planning Of Otologic And Neurotologic Procedures |
| 10/27/2022 |
K220332 |
UMR Omega With uWS-MR-MRS |
Shanghai United Imaging Healthcare Co.,Ltd. |
Radiology |
System, Nuclear Magnetic Resonance Imaging |
| 5/25/2022 |
K220416 |
SwiftMR |
Airs Medical Inc. |
Radiology |
System, Image Processing, Radiological |
| 6/23/2022 |
K220497 |
Columbo |
Smart Soft Healthcare Ad |
Radiology |
Automated Radiological Image Processing Software |
| 8/24/2022 |
K220598 |
Autocontour Model Radac V2 |
Radformation, Inc. |
Radiology |
Radiological Image Processing Software For Radiation Therapy |
| 12/1/2022 |
K220786 |
Star Apollo Mapping System |
Rhythm Al, Ltd |
Cardiovascular |
Computer, Diagnostic, Programmable |
| 6/17/2022 |
K220813 |
Art-Plan |
Therapanacea |
Radiology |
Radiological Image Processing Software For Radiation Therapy |
| 7/12/2022 |
K220814 |
Naeotom Alpha, Scan&Go Software |
Siemens Medical Solutions Usa, Inc. |
Radiology |
System, X-Ray, Tomography, Computed |
| 7/19/2022 |
K220815 |
Braininsight |
Hyperfine, Inc. |
Radiology |
Automated Radiological Image Processing Software |
| 7/27/2022 |
K220922 |
Cochlear Osia 2 System, Cochlear Osia Osi200 Implant, Cochlear Osia 2 Sound Processor, Cochlear Osia Fitting Software 2, Cochlear MRI Kit |
Cochlear Americas |
Ear Nose & Throat |
Active Implantable Bone Conduction Hearing System |
| 7/22/2022 |
K220940 |
Echopac Software Only, Echopac Plug-In |
Ge Medical Systems Ultrasound And Primary Care Diagnostics, |
Radiology |
Automated Radiological Image Processing Software |
| 7/20/2022 |
K220956 |
Libby Echo:Prio |
Dyad Medical, Inc |
Radiology |
Automated Radiological Image Processing Software |
| 5/23/2022 |
K221000 |
On3D |
3D Ons, Inc. |
Radiology |
System, Image Processing, Radiological |
| 6/20/2023 |
K221024 |
Tremoflo C2 Airwave Oscillometry System |
Thorasys Thoracic Medical Systems, Inc. |
Anesthesiology |
Impedance Measuring Device Utilizing Oscillation Techniques |
| 8/29/2022 |
K221100 |
Viz Rv/Lv |
Viz.Ai, Inc. |
Radiology |
Automated Radiological Image Processing Software |
| 7/18/2023 |
K221107 |
Trust |
Rgorithm Korea |
Dental |
Dental Abutment Design Software For Dental Laboratory |
| 2/1/2023 |
K221168 |
Tinnitogram Signal Generator |
Goldenear Company, Inc. |
Ear Nose & Throat |
Masker, Tinnitus |
| 9/21/2022 |
K221179 |
Somnometry |
Neumetry Medical Inc |
Neurology |
Automatic Event Detection Software For Polysomnograph With Electroencephalograph |
| 5/31/2022 |
K221248 |
Rapid Lvo |
Ischemaview Inc. |
Radiology |
Radiological Computer-Assisted Triage And Notification Software |
| 10/14/2022 |
K221305 |
AI-Rad Companion Organs Rt |
Siemens Medical Solutions Usa, Inc |
Radiology |
Radiological Image Processing Software For Radiation Therapy |
| 8/3/2022 |
K221347 |
Transpara 1.7.2 |
Screenpoint Medical B.V. |
Radiology |
Radiological Image Processing Software For Radiation Therapy |
| 9/29/2022 |
K221375 |
Curesight-Cs100 |
Novasight Ltd. |
Ophthalmic |
Digital Therapy Device For Amblyopia |
| 8/3/2022 |
K221432 |
Customize |
3D-Side SA |
Radiology |
Automated Radiological Image Processing Software |
| 10/6/2022 |
K221449 |
Genius Ai Detection 2.0 |
Hologic, Inc. |
Radiology |
Radiological Computer Assisted Detection/Diagnosis Software For Lesions Suspicious For Cancer |
| 2/23/2023 |
K221564 |
Brainomix 360 E-Aspects |
Brainomix Limited |
Radiology |
Computer-Assisted Diagnostic Software For Lesions Suspicious For Cancer |
| 2/24/2023 |
K221614 |
Tytocare Lung Sounds Analyzer |
Tyto Care Ltd. |
Anesthesiology |
Abnormal Breath Sound Device |
| 11/22/2022 |
K221624 |
Avenda Health AI Prostate Cancer Planning Software |
Avenda Health, Inc. |
Radiology |
Computer-Assisted Diagnostic Software For Lesions Suspicious For Cancer |
| 10/18/2022 |
K221632 |
Spine Camp™ |
Medical Metrics, Inc. |
Radiology |
Automated Radiological Image Processing Software |
| 11/4/2022 |
K221659 |
Luminopia One |
Luminopia, Inc. |
Ophthalmic |
Digital Therapy Device For Amblyopia |
| 3/9/2023 |
K221706 |
Accucontour |
Manteia Technologies Co., Ltd. |
Radiology |
Radiological Image Processing Software For Radiation Therapy |
| 2/28/2023 |
K221711 |
AccuICAS |
Arteryflow Technology Co., Ltd. |
Radiology |
System, X-Ray, Angiographic |
| 9/27/2022 |
K221738 |
Ns-Hglio |
Neosoma Inc. |
Radiology |
Automated Radiological Image Processing Software |
| 11/16/2022 |
K221762 |
BoneMRI V1.4 |
Mrlguidance B.V. |
Radiology |
Automated Radiological Image Processing Software |
| 1/27/2023 |
K221868 |
Qoca Image Smart Cxr Image Processing System |
Quanta Computer Inc. |
Radiology |
Radiological Computer-Assisted Prioritization Software For Lesions |
| 5/1/2023 |
K221870 |
Carnalife Holo |
Medapp S.A. |
Radiology |
System, Image Processing, Radiological |
| 3/29/2023 |
K221984 |
Interview XP; Interview Fusion |
Mediso Medical Imaging Systems, Lttd. |
Radiology |
System, Image Processing, Radiological |
| 3/22/2023 |
K222036 |
Mpxa-2000 |
Medipixel, Inc. |
Radiology |
Automated Radiological Image Processing Software |
| 8/19/2022 |
K222172 |
MI View&Go |
Siemens Medical Solutions Usa, Inc. |
Radiology |
Automated Radiological Image Processing Software |
| 3/28/2023 |
K222174 |
Radiolens V1.0 |
Synapsica |
Radiology |
Automated Radiological Image Processing Software |
| 3/2/2023 |
K222176 |
Boneview |
Gleamer |
Radiology |
Radiological Computer Assisted Detection/Diagnosis Software For Fracture |
| 10/12/2023 |
K222222 |
Artemis, Artemis Tpo, Artemis Mx |
Eigen |
Radiology |
Radiological Image Processing Software For Ablation Therapy Planning And Evaluation |
| 12/16/2022 |
K222275 |
Saige-Density |
Deephealth, Inc. |
Radiology |
Automated Radiological Image Processing Software |
| 1/23/2023 |
K222406 |
Clarius AI |
Clarius Mobile Health Corp. |
Radiology |
Automated Radiological Image Processing Software |
| 11/14/2022 |
K222428 |
Syngo Dynamics (Version Va40F) |
Siemens Medical Solutions Usa, Inc. |
Radiology |
Automated Radiological Image Processing Software |
| 11/23/2022 |
K222463 |
Echogo Heart Failure |
Ultromics Limited |
Cardiovascular |
Adjunctive Heart Failure Status Indicator |
| 1/27/2023 |
K222664 |
Sim&Size |
Sim&Cure |
Neurology |
Software For Visualization Of Vascular Anatomy And Intravascular Devices |
| 4/25/2023 |
K222676 |
Ceevra Reveal 3 |
Ceevra, Inc. |
Radiology |
Automated Radiological Image Processing Software |
| 2/2/2023 |
K222680 |
Deltascan Monitor |
Prolira B.V. |
Neurology |
Neuropsychiatric Interpretative Electroencephalograph Assessment Aid |
| 7/3/2023 |
K222745 |
Axial3D Insight |
Axial Medical Printing Limited |
Radiology |
Automated Radiological Image Processing Software |
| 3/2/2023 |
K222884 |
Rapid Ncct Stroke |
Ischemaview, Inc. |
Radiology |
Radiological Computer-Assisted Triage And Notification Software |
| 2/1/2023 |
K222970 |
Lvivo IQS |
Dia Imaging Analysis Ltd. |
Radiology |
Automated Radiological Image Processing Software |
| 11/21/2022 |
K223032 |
Sis System (Version 5.6.0) |
Surgical Information Sciences, Inc. |
Radiology |
Automated Radiological Image Processing Software |
| 7/14/2023 |
K223106 |
Brainlab Elements Image Fusion, Contouring (4.5);Image Fusion (4.5);Fibertracking (2.0);Bold MRI Mapping (1.0);Image Fusion Angio (1.0) |
Brainlab Ag |
Radiology |
Automated Radiological Image Processing Software |
| 8/3/2023 |
K223133 |
Visirad Xr |
Imidex Inc. |
Radiology |
Analyzer, Medical Image |
| 8/25/2023 |
K223180 |
AIRAscore |
AIRAmed GmbH |
Radiology |
System, Image Processing, Radiological |
| 12/16/2022 |
K223268 |
Braininsight |
Hyperfine, Inc. |
Radiology |
Automated Radiological Image Processing Software |
| 2/6/2023 |
K223296 |
Videa Perio Assist |
Videahealth, Inc |
Radiology |
Automated Radiological Image Processing Software |
| 2/1/2023 |
K223396 |
Rapid Rv/Lv |
Ischemaview Inc. |
Radiology |
Automated Radiological Image Processing Software |
| 5/25/2023 |
K223491 |
Critical Care Suite With Pneumothorax Detection Ai Algorithm, Critical Care Suite 2.1, Critical Care Suite |
Ge Medical Systems, LLC |
Radiology |
Radiological Computer Assisted Detection/Diagnosis Software For Fracture |
| 4/21/2023 |
K223501 |
Viewfinder Software Version 1.1 |
Elaitra Ltd |
Radiology |
Automated Radiological Image Processing Software |
| 6/13/2023 |
K223518 |
Iortho |
Shanghai Ea Medical Instruments Co., Ltd. |
Dental |
Orthodontic Software |
| 6/16/2023 |
K223556 |
Deepcatch |
Medicalip Co., Ltd |
Radiology |
Automated Radiological Image Processing Software |
| 7/7/2023 |
K223578 |
T3 Platform Software |
Etiometry, Inc. |
Cardiovascular |
Adjunctive Cardiovascular Status Indicator |
| 5/11/2023 |
K223623 |
Subtlemr (2.3.X) |
Subtle Medical Inc. |
Radiology |
System, Image Processing, Radiological |
| 8/28/2023 |
K223639 |
Visable.Io |
Techsomed |
Radiology |
Radiological Image Processing Software For Ablation Therapy Planning And Evaluation |
| 6/16/2023 |
K223646 |
Ib Lab Lama |
Ib Lab GmbH |
Radiology |
Automated Radiological Image Processing Software |
| 9/22/2023 |
K223659 |
Jazz |
Ai Medical AG |
Radiology |
System, Image Processing, Radiological |
| 4/6/2023 |
K223774 |
Contour ProtegeAI |
Mim Software Inc. |
Radiology |
Radiological Image Processing Software For Radiation Therapy |
| 6/6/2023 |
K223855 |
FEops HEARTguideTM, FEops HEARTguideTM ALPACA |
Feops Nv |
Radiology |
Automated Radiological Image Processing Software |
| 10/6/2023 |
K223905 |
Vivio® LVEDP System |
Avicena, LLC |
Cardiovascular |
Adjunctive Heart Failure Status Indicator |
| 6/8/2023 |
K230008 |
Ablamapâ® System |
Ablacon, Inc. |
Cardiovascular |
Computer, Diagnostic, Programmable |
| 2/2/2023 |
K230012 |
Atomica Planner |
Atomica Technology, Inc. |
Radiology |
System, Image Processing, Radiological |
| 4/19/2023 |
K230023 |
Art-Plan |
Therapanacea Sas |
Radiology |
Radiological Image Processing Software For Radiation Therapy |
| 7/20/2023 |
K230039 |
Uomnispace |
Shanghai United Imaging Healthcare Co., Ltd. |
Radiology |
Automated Radiological Image Processing Software |
| 5/4/2023 |
K230082 |
Auto Segmentation |
Ge Medical Systems, LLC |
Radiology |
Radiological Image Processing Software For Radiation Therapy |
| 5/23/2023 |
K230096 |
Genius Ai Detection 2.0 With Cc-Mlo Correlation |
Hologic, Inc. |
Radiology |
Radiological Computer Assisted Detection/Diagnosis Software For Lesions Suspicious For Cancer |
| 6/13/2023 |
K230112 |
Cac Software |
Imbio, Inc. |
Radiology |
System, X-Ray, Tomography, Computed |
| 7/21/2023 |
K230150 |
OptimMRI |
Rebrain, Sas |
Radiology |
Automated Radiological Image Processing Software |
| 9/29/2023 |
K230187 |
Terran Nm-101 |
Terran Biosciences, Inc. |
Radiology |
System, Nuclear Magnetic Resonance Imaging |
| 2/22/2023 |
K230197 |
BoneMRI V1.6 |
MRIguidance B.V |
Radiology |
Automated Radiological Image Processing Software |
| 10/20/2023 |
K230209 |
Sonix Health |
Ontact Health Co., Ltd. |
Radiology |
Automated Radiological Image Processing Software |
| 6/2/2023 |
K230214 |
Huma RPM (RPM) |
Medopad Inc |
Cardiovascular |
Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms) |
| 4/25/2023 |
K230223 |
ICAC Device |
Bunkerhill, Inc |
Radiology |
System, X-Ray, Tomography, Computed |
| 4/13/2023 |
K230264 |
Ezra Flash |
Ezra Ai, Inc. |
Radiology |
System, Image Processing, Radiological |
| 5/2/2023 |
K230292 |
Samsung ECG Monitor Application With Irregular Heart Rhythm Notification |
Samsung Electronics Co., Ltd |
Cardiovascular |
Electrocardiograph Software For Over-The-Counter Use |
| 3/2/2023 |
K230303 |
AccuFFRangio Plus |
Arteryflow Technology Co., Ltd. |
Radiology |
System, X-Ray, Angiographic |
| 7/25/2023 |
K230365 |
Sonio Detect |
Sonio |
Radiology |
System, Imaging, Pulsed Doppler, Ultrasonic |
| 5/17/2023 |
K230448 |
Deepx Dermosight Dermatoscope |
Deepx Health LLC |
General & Plastic Surgery |
Light Based Imaging |
| 6/22/2023 |
K230497 |
Bladder Ai (Aibv01) |
Exo Inc |
Radiology |
Automated Radiological Image Processing Software |
| 11/8/2023 |
K230534 |
Briefcase-Quantification |
Aidoc Medical, Ltd. |
Radiology |
Automated Radiological Image Processing Software |
| 4/7/2023 |
K230575 |
Limbus Contour |
Limbus Ai Inc. |
Radiology |
System, Image Processing, Radiological |
| 4/14/2023 |
K230685 |
Autocontour Model Radac V3 |
Radformation, Inc. |
Radiology |
Radiological Image Processing Software For Radiation Therapy |
| 5/23/2023 |
K230803 |
Adas 3D |
Adas3D Medical S.L |
Radiology |
System, Image Processing, Radiological |
| 7/28/2023 |
K230813 |
Bluestar And BlueStar Rx |
Welldoc, Inc. |
Clinical Chemistry |
Calculator, Drug Dose |
| 10/25/2023 |
K230842 |
Signalhf (Im008) |
Implicity Inc. |
Cardiovascular |
Medium-Term Adjunctive Predictive Cardiovascular Indicator |
| 10/27/2023 |
K230854 |
SwiftMR |
Airs Medical Inc. |
Radiology |
System, Image Processing, Radiological |
| 7/25/2023 |
K230913 |
Andi |
Imeka Solutions, Inc. |
Radiology |
Automated Radiological Image Processing Software |
| 5/2/2023 |
K230977 |
Sis System |
Surgical Information Sciences, Inc. |
Radiology |
Automated Radiological Image Processing Software |
| 7/14/2023 |
K231041 |
Jivex (Model Number / Release: 5.4) |
Visus Health It GmbH |
Radiology |
System, Image Processing, Radiological |
| 9/1/2023 |
K231047 |
Unisyn Molecular Imaging (6-3-1) |
Convergent Imaging Solutions |
Radiology |
System, Image Processing, Radiological |
| 7/19/2023 |
K231157 |
Syngo.Ct Lung CAD (Version Vd30) |
Siemens Healthcare GmbH |
Radiology |
Lung Computed Tomography System, Computer-Aided Detection |
| 7/21/2023 |
K231173 |
Irregular Rhythm Notification Feature (Irnf) |
Apple Inc. |
Cardiovascular |
Photoplethysmograph Analysis Software For Over-The-Counter Use |
| 7/27/2023 |
K231195 |
Brainomix 360 Triage ICH |
Brainomix Limited |
Radiology |
Radiological Computer-Assisted Triage And Notification Software |
| 8/18/2023 |
K231204 |
Cochlear™ Osia® System; Cochlear™ Osia® OSI300 Implant; Cochlear™ Magnet Cassette; Cochlear™ Non-Magnetic Cassette; Cochlear™ Osia® 2(I) Sound Processor; Cochlear™ Osia® Fitting Software 2; Cochlear™ Osia® Smart App |
Cochlear |
Ear Nose & Throat |
Active Implantable Bone Conduction Hearing System |
| 8/24/2023 |
K231274 |
Natural Cycles |
Natural Cycles Nordic AB |
Obstetrics/Gynecology |
Device, Fertility Diagnostic, Contraceptive, Software Application |
| 9/8/2023 |
K231335 |
Cleerly Ischemia |
Cleerly, Inc |
Cardiovascular |
Adjunctive Epicardial Vascular Physiologic Status Indicator |
| 9/20/2023 |
K231385 |
Rology Teleradiology Platform (V.1.22.1103) |
Rology Inc. |
Radiology |
System, Image Processing, Radiological |
| 10/4/2023 |
K231398 |
Vuno Med-Deepbrain |
Vuno Inc. |
Radiology |
Automated Radiological Image Processing Software |
| 8/18/2023 |
K231457 |
Spark Scan |
Spark Neuro Inc. |
Neurology |
Full-Montage Standard Electroencephalograph |
| 6/20/2023 |
K231459 |
Hepafatsmart (V2.0.0) |
Resonance Health Analysis Services Pty Ltd |
Radiology |
System, Nuclear Magnetic Resonance Imaging |
| 11/6/2023 |
K231470 |
Lunit Insight Dbt |
Lunit Inc. |
Radiology |
Radiological Computer Assisted Detection/Diagnosis Software For Lesions Suspicious For Cancer |
| 8/22/2023 |
K231503 |
CUPTIMIZE™ Advanced |
Depuy Orthopaedics, Inc |
Radiology |
System, Image Processing, Radiological |
| 7/7/2023 |
K231668 |
Spine Camp™ (1.1) |
Medical Metrics, Inc |
Radiology |
Automated Radiological Image Processing Software |
| 9/16/2023 |
K231688 |
Impact Version 4 |
Impact Applications, Inc. |
Neurology |
Computerized Cognitive Assessment Aid For Concussion |
| 11/8/2023 |
K231765 |
Contour ProtegeAI |
Mim Software Inc. |
Radiology |
Radiological Image Processing Software For Radiation Therapy |
| 10/18/2023 |
K231824 |
Smartbolus Calculator |
Insulet Corporation |
Clinical Chemistry |
Continuous Glucose Monitor Informed Insulin Dose Calculator |
| 9/28/2023 |
K231837 |
Brainomix 360 Triage LVO |
Brainomix Limited |
Radiology |
Radiological Computer-Assisted Triage And Notification Software |
| 11/3/2023 |
K231955 |
Aprevo® Digital Segmentation |
Carlsmed, Inc. |
Radiology |
Automated Radiological Image Processing Software |
| 11/13/2023 |
K232083 |
Briefcase-Quantification |
Aidoc Medical, Ltd. |
Radiology |
Automated Radiological Image Processing Software |
| 8/8/2023 |
K232100 |
Efai PACS Picture Archiving And Communication System Pro |
Ever Fortune.Ai Co., Ltd. |
Radiology |
System, Image Processing, Radiological |
| 11/13/2023 |
K232257 |
Clarius Bladder AI |
Clarius Mobile Health Corp. |
Radiology |
Automated Radiological Image Processing Software |
| 10/23/2023 |
K232305 |
AI-Rad Companion Brain MR |
Siemens Medical Solutions U.S.A. |
Radiology |
Automated Radiological Image Processing Software |
| 10/5/2023 |
K232367 |
Cmangio® V1.0 |
Curemetrix, Inc. |
Radiology |
Automated Radiological Image Processing Software |
| 10/13/2023 |
K232429 |
Titan Dental Design |
Clearadvance, LLC |
Dental |
Orthodontic Software |
| 11/21/2023 |
K232496 |
Brainomix 360 Triage Stroke |
Brainomix Limited |
Radiology |
Radiological Computer-Assisted Triage And Notification Software |
| 11/17/2023 |
K232501 |
Ai Platform (Aip001) |
Exo Inc |
Radiology |
Automated Radiological Image Processing Software |
| 11/21/2023 |
K232549 |
Nemocast |
Software Nemotec S.L. |
Dental |
Orthodontic Software |
| 9/28/2023 |
K232699 |
Low Ejection Fraction AI-ECG Algorithm |
Anumana, Inc. |
Cardiovascular |
Reduced Ejection Fraction Machine Learning-Based Notification Software |
| 10/6/2023 |
K232787 |
Scannav Anatomy Peripheral Nerve Block |
Intelligent Ultrasound Limited |
Anesthesiology |
Ultrasound Guided Nerve Block Assist |
| 11/15/2023 |
K232841 |
Axial3D Insight |
Axial Medical Printing Limited |
Radiology |
Automated Radiological Image Processing Software |
| 11/27/2023 |
K233243 |
Clearpoint System (Software Version 2.2) |
Clearpoint Neuro Inc. |
Neurology |
Neurological Stereotaxic Instrument |
| 8/19/1996 |
K962699 |
Radworks Medical Imaging Software |
Applicare Medical Imaging, B.V. |
Radiology |
System, Digital Image Communications, Radiological |
| 10/27/1997 |
K972933 |
Vox/Base For Windows |
J-Mac System, Inc. |
Radiology |
System, Image Processing, Radiological |
| 9/29/1999 |
K992352 |
Itr2000: Internet Teleradiology, Model Release 1.0 |
Inteleradiology, Inc. |
Radiology |
System, Digital Image Communications, Radiological |
| 2/2/2000 |
K993750 |
Prosolv Echoviewer, Prosolv Echoviewer Se, Prosolv Echoanalyzer, Prosolv Echoserv, Prosolv Echo |
Problem Solving Concepts, Inc. |
Radiology |
System, Image Processing, Radiological |
| 12/28/1999 |
K993761 |
Cardiovascular Measurement System – View |
Medis Medical Imaging Systems, B.V. |
Radiology |
System, Image Processing, Radiological |
| 11/26/1999 |
K993763 |
Quantitative Analysis Of Coronary Angiograms (Qca) |
Medis Medical Imaging Systems, B.V. |
Radiology |
System, X-Ray, Angiographic |
| 11/26/1999 |
K993765 |
Quantitative Analysis Of Left Ventricular Angiograms (Qlv) |
Medis Medical Imaging Systems, B.V. |
Radiology |
System, X-Ray, Angiographic |
| 8/30/2000 |
K994283 |
MRI- Magnetic Resonance Analytical Software System |
Medis Medical Imaging Systems, B.V. |
Radiology |
System, Nuclear Magnetic Resonance Imaging |
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- Source: https://orthogonal.io/insights/fda/list-of-483-fda-cleared-software-as-a-medical-device-samd/
