White Paper
Software as a Medical Device (SaMD): What It Is & Why It Matters
This list, created by Orthogonal and Brian Binkowski, contains information on 483 individual Software as a Medical Devices (SaMD) cleared by the FDA. The data used to create this list was pulled from publicly available sources such archived reports from the FDA and Basil System’s regulatory search tools. As this list is a work in progress, we invite members of the MedTech and digital health industries to submit comments and revisions in order to improve its accuracy. Submit comments via this form or email us at [email protected].
Learn about the methodology used to create this list by reading our accompanying blog.
Device | Company | Date of Final Decision | Panel (Lead) |
---|---|---|---|
Clearpoint System (Software Version 2.2) | Clearpoint Neuro Inc. | 11/27/2023 | Neurology |
Brainomix 360 Triage Stroke | Brainomix Limited | 11/21/2023 | Radiology |
Nemocast | Software Nemotec S.L. | 11/21/2023 | Dental |
Ai Platform (Aip001) | Exo Inc | 11/17/2023 | Radiology |
Axial3D Insight | Axial Medical Printing Limited | 11/15/2023 | Radiology |
Briefcase-Quantification | Aidoc Medical, Ltd. | 11/13/2023 | Radiology |
Clarius Bladder AI | Clarius Mobile Health Corp. | 11/13/2023 | Radiology |
Briefcase-Quantification | Aidoc Medical, Ltd. | 11/8/2023 | Radiology |
Contour ProtegeAI | Mim Software Inc. | 11/8/2023 | Radiology |
Lunit Insight Dbt | Lunit Inc. | 11/6/2023 | Radiology |
Aprevo® Digital Segmentation | Carlsmed, Inc. | 11/3/2023 | Radiology |
SwiftMR | Airs Medical Inc. | 10/27/2023 | Radiology |
Signalhf (Im008) | Implicity Inc. | 10/25/2023 | Cardiovascular |
AI-Rad Companion Brain MR | Siemens Medical Solutions U.S.A. | 10/23/2023 | Radiology |
Sonix Health | Ontact Health Co., Ltd. | 10/20/2023 | Radiology |
Smartbolus Calculator | Insulet Corporation | 10/18/2023 | Clinical Chemistry |
Titan Dental Design | Clearadvance, LLC | 10/13/2023 | Dental |
Artemis, Artemis Tpo, Artemis Mx | Eigen | 10/12/2023 | Radiology |
Vivio® LVEDP System | Avicena, LLC | 10/6/2023 | Cardiovascular |
Scannav Anatomy Peripheral Nerve Block | Intelligent Ultrasound Limited | 10/6/2023 | Anesthesiology |
Cmangio® V1.0 | Curemetrix, Inc. | 10/5/2023 | Radiology |
Vuno Med-Deepbrain | Vuno Inc. | 10/4/2023 | Radiology |
Terran Nm-101 | Terran Biosciences, Inc. | 9/29/2023 | Radiology |
Brainomix 360 Triage LVO | Brainomix Limited | 9/28/2023 | Radiology |
Low Ejection Fraction AI-ECG Algorithm | Anumana, Inc. | 9/28/2023 | Cardiovascular |
Jazz | Ai Medical AG | 9/22/2023 | Radiology |
Rology Teleradiology Platform (V.1.22.1103) | Rology Inc. | 9/20/2023 | Radiology |
Impact Version 4 | Impact Applications, Inc. | 9/16/2023 | Neurology |
Cleerly Ischemia | Cleerly, Inc | 9/8/2023 | Cardiovascular |
Unisyn Molecular Imaging (6-3-1) | Convergent Imaging Solutions | 9/1/2023 | Radiology |
Visable.Io | Techsomed | 8/28/2023 | Radiology |
AIRAscore | AIRAmed GmbH | 8/25/2023 | Radiology |
Natural Cycles | Natural Cycles Nordic AB | 8/24/2023 | Obstetrics/Gynecology |
CUPTIMIZE™ Advanced | Depuy Orthopaedics, Inc | 8/22/2023 | Radiology |
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 | 8/18/2023 | Ear Nose & Throat |
Spark Scan | Spark Neuro Inc. | 8/18/2023 | Neurology |
Efai PACS Picture Archiving And Communication System Pro | Ever Fortune.Ai Co., Ltd. | 8/8/2023 | Radiology |
Visirad Xr | Imidex Inc. | 8/3/2023 | Radiology |
Bluestar And BlueStar Rx | Welldoc, Inc. | 7/28/2023 | Clinical Chemistry |
Brainomix 360 Triage ICH | Brainomix Limited | 7/27/2023 | Radiology |
Sonio Detect | Sonio | 7/25/2023 | Radiology |
Andi | Imeka Solutions, Inc. | 7/25/2023 | Radiology |
OptimMRI | Rebrain, Sas | 7/21/2023 | Radiology |
Irregular Rhythm Notification Feature (Irnf) | Apple Inc. | 7/21/2023 | Cardiovascular |
Uomnispace | Shanghai United Imaging Healthcare Co., Ltd. | 7/20/2023 | Radiology |
Syngo.Ct Lung CAD (Version Vd30) | Siemens Healthcare GmbH | 7/19/2023 | Radiology |
Trust | Rgorithm Korea | 7/18/2023 | Dental |
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 | 7/14/2023 | Radiology |
Jivex (Model Number / Release: 5.4) | Visus Health It GmbH | 7/14/2023 | Radiology |
T3 Platform Software | Etiometry, Inc. | 7/7/2023 | Cardiovascular |
Spine Camp™ (1.1) | Medical Metrics, Inc | 7/7/2023 | Radiology |
Axial3D Insight | Axial Medical Printing Limited | 7/3/2023 | Radiology |
Blood Establishment Computer Software And Accessories | GPI USA, Inc. | 6/26/2023 | Hematology |
Bladder Ai (Aibv01) | Exo Inc | 6/22/2023 | Radiology |
Tremoflo C2 Airwave Oscillometry System | Thorasys Thoracic Medical Systems, Inc. | 6/20/2023 | Anesthesiology |
Hepafatsmart (V2.0.0) | Resonance Health Analysis Services Pty Ltd | 6/20/2023 | Radiology |
Deepcatch | Medicalip Co., Ltd | 6/16/2023 | Radiology |
Ib Lab Lama | Ib Lab GmbH | 6/16/2023 | Radiology |
Iortho | Shanghai Ea Medical Instruments Co., Ltd. | 6/13/2023 | Dental |
Cac Software | Imbio, Inc. | 6/13/2023 | Radiology |
Ablamapâ® System | Ablacon, Inc. | 6/8/2023 | Cardiovascular |
FEops HEARTguideTM, FEops HEARTguideTM ALPACA | Feops Nv | 6/6/2023 | Radiology |
Huma RPM (RPM) | Medopad Inc | 6/2/2023 | Cardiovascular |
Critical Care Suite With Pneumothorax Detection Ai Algorithm, Critical Care Suite 2.1, Critical Care Suite | Ge Medical Systems, LLC | 5/25/2023 | Radiology |
Genius Ai Detection 2.0 With Cc-Mlo Correlation | Hologic, Inc. | 5/23/2023 | Radiology |
Adas 3D | Adas3D Medical S.L | 5/23/2023 | Radiology |
Autoplaque | Cedars-Sinai Medical Center: Aim | 5/19/2023 | Radiology |
Deepx Dermosight Dermatoscope | Deepx Health LLC | 5/17/2023 | General & Plastic Surgery |
Subtlemr (2.3.X) | Subtle Medical Inc. | 5/11/2023 | Radiology |
Auto Segmentation | Ge Medical Systems, LLC | 5/4/2023 | Radiology |
Samsung ECG Monitor Application With Irregular Heart Rhythm Notification | Samsung Electronics Co., Ltd | 5/2/2023 | Cardiovascular |
Sis System | Surgical Information Sciences, Inc. | 5/2/2023 | Radiology |
Carnalife Holo | Medapp S.A. | 5/1/2023 | Radiology |
Ceevra Reveal 3 | Ceevra, Inc. | 4/25/2023 | Radiology |
ICAC Device | Bunkerhill, Inc | 4/25/2023 | Radiology |
Viewfinder Software Version 1.1 | Elaitra Ltd | 4/21/2023 | Radiology |
Art-Plan | Therapanacea Sas | 4/19/2023 | Radiology |
Autocontour Model Radac V3 | Radformation, Inc. | 4/14/2023 | Radiology |
Cerebralgo Plus | Yukun (Beijing) Technology Co., Ltd | 4/13/2023 | Radiology |
Ezra Flash | Ezra Ai, Inc. | 4/13/2023 | Radiology |
Limbus Contour | Limbus Ai Inc. | 4/7/2023 | Radiology |
Contour ProtegeAI | Mim Software Inc. | 4/6/2023 | Radiology |
Formus Hip | Formus Labs, Ltd | 3/31/2023 | Radiology |
Interview XP; Interview Fusion | Mediso Medical Imaging Systems, Lttd. | 3/29/2023 | Radiology |
Radiolens V1.0 | Synapsica | 3/28/2023 | Radiology |
Mpxa-2000 | Medipixel, Inc. | 3/22/2023 | Radiology |
Accucontour | Manteia Technologies Co., Ltd. | 3/9/2023 | Radiology |
Boneview | Gleamer | 3/2/2023 | Radiology |
Rapid Ncct Stroke | Ischemaview, Inc. | 3/2/2023 | Radiology |
AccuFFRangio Plus | Arteryflow Technology Co., Ltd. | 3/2/2023 | Radiology |
AccuICAS | Arteryflow Technology Co., Ltd. | 2/28/2023 | Radiology |
Caption Interpretation Automated Ejection Fraction Software | Caption Health, Inc | 2/24/2023 | Radiology |
Tytocare Lung Sounds Analyzer | Tyto Care Ltd. | 2/24/2023 | Anesthesiology |
Brainomix 360 E-Aspects | Brainomix Limited | 2/23/2023 | Radiology |
3D-RD-S | Radiopharmaceutical Imaging And Dosimetry, LLC | 2/22/2023 | Radiology |
BoneMRI V1.6 | MRIguidance B.V | 2/22/2023 | Radiology |
PMD-200 | Medasense Biometrics Ltd. | 2/17/2023 | Anesthesiology |
Videa Perio Assist | Videahealth, Inc | 2/6/2023 | Radiology |
Deltascan Monitor | Prolira B.V. | 2/2/2023 | Neurology |
Atomica Planner | Atomica Technology, Inc. | 2/2/2023 | Radiology |
Tinnitogram Signal Generator | Goldenear Company, Inc. | 2/1/2023 | Ear Nose & Throat |
Lvivo IQS | Dia Imaging Analysis Ltd. | 2/1/2023 | Radiology |
Rapid Rv/Lv | Ischemaview Inc. | 2/1/2023 | Radiology |
Qoca Image Smart Cxr Image Processing System | Quanta Computer Inc. | 1/27/2023 | Radiology |
Sim&Size | Sim&Cure | 1/27/2023 | Neurology |
Tidepool Loop | Tidepool Project | 1/23/2023 | Clinical Chemistry |
Clarius AI | Clarius Mobile Health Corp. | 1/23/2023 | Radiology |
T3 Platform Software | Etiometry. Inc. | 1/6/2023 | Cardiovascular |
Aview | Coreline Soft Co.,Ltd. | 12/23/2022 | Radiology |
Saige-Density | Deephealth, Inc. | 12/16/2022 | Radiology |
Braininsight | Hyperfine, Inc. | 12/16/2022 | Radiology |
Star Apollo Mapping System | Rhythm Al, Ltd | 12/1/2022 | Cardiovascular |
Echogo Heart Failure | Ultromics Limited | 11/23/2022 | Cardiovascular |
Avenda Health AI Prostate Cancer Planning Software | Avenda Health, Inc. | 11/22/2022 | Radiology |
Sis System (Version 5.6.0) | Surgical Information Sciences, Inc. | 11/21/2022 | Radiology |
BoneMRI V1.4 | Mrlguidance B.V. | 11/16/2022 | Radiology |
Syngo Dynamics (Version Va40F) | Siemens Medical Solutions Usa, Inc. | 11/14/2022 | Radiology |
Luminopia One | Luminopia, Inc. | 11/4/2022 | Ophthalmic |
UMR Omega With uWS-MR-MRS | Shanghai United Imaging Healthcare Co.,Ltd. | 10/27/2022 | Radiology |
Intraop Vsp Software Device | Xironetic, LLC | 10/21/2022 | Radiology |
Spine Camp™ | Medical Metrics, Inc. | 10/18/2022 | Radiology |
Heartflow Analysis | Heartflow, Inc. | 10/14/2022 | Cardiovascular |
AI-Rad Companion Organs Rt | Siemens Medical Solutions Usa, Inc | 10/14/2022 | Radiology |
Genius Ai Detection 2.0 | Hologic, Inc. | 10/6/2022 | Radiology |
Blood Establishment Computer Software And Accessories | Diagnostic Grifols, S. A. | 10/4/2022 | Hematology |
QIR Suite | Casis Cardiac Simulation & Imaging Software | 9/30/2022 | Radiology |
Cognet Qmtriage | Medcognetics, Inc. | 9/29/2022 | Radiology |
Curesight-Cs100 | Novasight Ltd. | 9/29/2022 | Ophthalmic |
Ns-Hglio | Neosoma Inc. | 9/27/2022 | Radiology |
Somnometry | Neumetry Medical Inc | 9/21/2022 | Neurology |
EyeCTester | Neuro-Eye Diagnostic Systems LLC | 9/7/2022 | Ophthalmic |
Viz Rv/Lv | Viz.Ai, Inc. | 8/29/2022 | Radiology |
MRI Planner | Spectronic Medical AB | 8/25/2022 | Radiology |
Autocontour Model Radac V2 | Radformation, Inc. | 8/24/2022 | Radiology |
MI View&Go | Siemens Medical Solutions Usa, Inc. | 8/19/2022 | Radiology |
Clearpoint Maestro Brain Model | Clearpoint Neuro, Inc. | 8/8/2022 | Radiology |
Transpara 1.7.2 | Screenpoint Medical B.V. | 8/3/2022 | Radiology |
Customize | 3D-Side SA | 8/3/2022 | Radiology |
Cvi42 Auto Imaging Software Application | Circle Cardiovascular Imaging Inc | 7/28/2022 | Radiology |
Cochlear Osia 2 System, Cochlear Osia Osi200 Implant, Cochlear Osia 2 Sound Processor, Cochlear Osia Fitting Software 2, Cochlear MRI Kit | Cochlear Americas | 7/27/2022 | Ear Nose & Throat |
Echopac Software Only, Echopac Plug-In | Ge Medical Systems Ultrasound And Primary Care Diagnostics, | 7/22/2022 | Radiology |
Libby Echo:Prio | Dyad Medical, Inc | 7/20/2022 | Radiology |
Zeus System (Zio Watch) | Irhythm Technologies, Inc. | 7/19/2022 | Cardiovascular |
Braininsight | Hyperfine, Inc. | 7/19/2022 | Radiology |
Naeotom Alpha, Scan&Go Software | Siemens Medical Solutions Usa, Inc. | 7/12/2022 | Radiology |
Prostatid | Scanmed, LLC | 7/8/2022 | Radiology |
Otoplan | Cascination Ag | 6/24/2022 | Ear Nose & Throat |
Columbo | Smart Soft Healthcare Ad | 6/23/2022 | Radiology |
T3 Platform Software | Etiometry, Inc. | 6/22/2022 | Cardiovascular |
Art-Plan | Therapanacea | 6/17/2022 | Radiology |
eCareManager 4.5 | Visicu, Inc. | 6/3/2022 | Cardiovascular |
Atrial Fibrillation History Feature | Apple Inc. | 6/3/2022 | Cardiovascular |
Rayvolve | Azmed Sas | 6/2/2022 | Radiology |
Efai Cardiosuite Spect Myocardial Perfusion Agile Workflows | Ever Fortune.Ai Co., Ltd. | 5/31/2022 | Radiology |
Rapid Lvo | Ischemaview Inc. | 5/31/2022 | Radiology |
SwiftMR | Airs Medical Inc. | 5/25/2022 | Radiology |
On3D | 3D Ons, Inc. | 5/23/2022 | Radiology |
Saige-Dx | Deephealth, Inc. | 5/12/2022 | Radiology |
MVision AI Segmentation | MVision AI | 5/3/2022 | Radiology |
Efai RTsuite Ct Hn-Segmentation System | Ever Fortune.Ai Co., Ltd. | 4/28/2022 | Radiology |
Alivecor QT Service | Alivecor, Inc. | 4/26/2022 | Cardiovascular |
CER-S | Cardiocalm Srl | 4/25/2022 | Cardiovascular |
AI-Rad Companion Brain MR | Siemens Healthcare GmbH | 4/15/2022 | Radiology |
Fitbit Irregular Rhythm Notifications | Fitbit Inc | 4/8/2022 | Cardiovascular |
EFAI Intelligent Cardiothoracic Ratio (iCTR) Assessment System | Ever Fortune. Ai Co., Ltd. | 4/4/2022 | Radiology |
Deepvessel Ffr | Keyamed Na Inc. | 4/1/2022 | Cardiovascular |
Customize | 3D-Side SA | 3/16/2022 | Radiology |
Arterys MICA | Arterys Inc. | 3/14/2022 | Radiology |
RI.Hip Modeler | Blue Belt Technologies, Inc. | 3/11/2022 | Radiology |
Demetra Dermatoscope BDEM-01 | Barco Nv | 3/11/2022 | General & Plastic Surgery |
Boneview | Gleamer | 3/1/2022 | Radiology |
Zyter RPM | Zyter, Inc. | 2/11/2022 | Cardiovascular |
Rapid | Ischema View Inc. | 2/8/2022 | Radiology |
Micro C Medical Imaging System, M01 | Oxos Medical, Inc. | 2/4/2022 | Radiology |
Veuron-Brain-Pab2 | Heuron Co., Ltd. | 2/4/2022 | Radiology |
Contour ProtegeAI | Mim Software Inc. | 2/3/2022 | Radiology |
Caption Interpretation Automated Ejection Fraction Software | Caption Health | 1/19/2022 | Radiology |
Follicle Clarity | Cycle Clarity | 1/19/2022 | Radiology |
Precise Image | Philips Medical Systems Nederland, B.V. | 1/14/2022 | Radiology |
Eclipse Ii With Smart Noise Cancellation | Carestream Health, Inc. | 1/14/2022 | Radiology |
Unid Spine Analyzer | Medicrea International, Inc. | 1/12/2022 | Radiology |
Tomtec-Arena | Tomtec Imaging Systems GmbH | 1/6/2022 | Radiology |
BoneMRI | MRIguidance B.V | 12/22/2021 | Radiology |
Claritas Ipet | Claritas Healthtech Pte Ltd | 12/22/2021 | Radiology |
BU-CAD | Taihao Medical Inc. | 12/21/2021 | Radiology |
qXR-BT | Qure.Ai Technologies | 12/21/2021 | Radiology |
Echogo Core (2.0) | Ultromics Limited | 12/20/2021 | Radiology |
Koios DS | Koios Medical, Inc. | 12/16/2021 | Radiology |
Vbrain | Vysioneer Inc. | 12/16/2021 | Radiology |
Archform Orthodontic Software System | Archform, Inc | 12/16/2021 | Dental |
Rt-Mind-AI | Medmind Technology Co., Ltd. | 12/15/2021 | Radiology |
LVivo Seamless V2.0 | Dia Imaging Analysis Ltd | 12/9/2021 | Radiology |
Implastation | Prodigident, Inc. | 12/3/2021 | Radiology |
Encevis | Austrian Institute Of Technology GmbH | 12/2/2021 | Neurology |
Mammoscreen 2.0 | Therapixel | 11/26/2021 | Radiology |
Regulora | Metame Health, Inc. | 11/24/2021 | Gastroenterology/Urology |
Myomics Q | Phantomics Inc. | 11/23/2021 | Radiology |
Hypotension Decision Assist Model Hda-Or2 | Directed Systems Ltd | 11/23/2021 | Cardiovascular |
ONQ Neuro | Cortechs Labs, Inc. | 11/19/2021 | Radiology |
EndoScreener | Chengdu Wision Medical Device Co., Ltd. | 11/19/2021 | Gastroenterology/Urology |
Lunit Insight Mmg | Lunit Inc. | 11/17/2021 | Radiology |
Intellijoint View | Intellijoint Surgical Inc. | 11/12/2021 | Radiology |
RTapp | Segana, Inc. | 11/10/2021 | Radiology |
Hura CTP v1.0 | Hura Imaging, Inc. | 11/8/2021 | Radiology |
Critical Care Suite With Endotracheal Tube Positing Ai Algorithm | Ge Medical Systems, LLC | 10/29/2021 | Radiology |
Advanced Algorithms For Treatment Management Applications (Aatma) | Elekta Solutions Ab | 10/25/2021 | Radiology |
IRNF App | Apple Inc. | 10/22/2021 | Cardiovascular |
Contour ProtegeAI | Mim Software Inc. | 10/20/2021 | Radiology |
iRAD | Claritas Healthtech Pte Ltd | 10/20/2021 | Radiology |
SwiftMR | Airs Medical Inc. | 10/14/2021 | Radiology |
Vbrain-Oar | Vysioneer Inc. | 10/12/2021 | Radiology |
Brius Planner Software | Brius Technologies Inc | 10/1/2021 | Dental |
Naeotom Alpha, Scan&Go | Siemens Medical Solutions Usa, Inc. | 9/30/2021 | Radiology |
JiveX (Model Number / Release: 5.3) | Visus Health It GmbH | 9/23/2021 | Radiology |
Paige Prostate | Paige.AI | 9/21/2021 | Pathology |
ClariSIGMAM | Claripi Inc. | 9/10/2021 | Radiology |
AccuFFRangio | Arteryflow Technology Co., Ltd. | 9/10/2021 | Radiology |
EFAI PACS Picture Archiving and Communication System | Ever Fortune.Ai Co., Ltd. | 9/10/2021 | Radiology |
FEops HEARTguide | Feops NV | 9/8/2021 | Cardiovascular |
BlueStar Rx | Welldoc, Inc | 9/8/2021 | Clinical Chemistry |
AmCAD-UT | Amcad Biomed Corporation | 9/8/2021 | Radiology |
ADAS 3D | Adas3D Medical S.L | 9/3/2021 | Radiology |
Ablamap Software | Ablacon, Inc. | 8/31/2021 | Cardiovascular |
Rbknee | Radiobotics Aps | 8/27/2021 | Radiology |
Otoplan | Cascination Ag | 8/20/2021 | Ear Nose & Throat |
Breastscape V1.0 | Olea Medical | 8/2/2021 | Radiology |
qER-Quant | Qure.Ai Technologies | 7/30/2021 | Radiology |
Us2.V1 | Eko.Ai Pte. Ltd. D/B/A Us2.Ai | 7/27/2021 | Radiology |
Change Healthcare Anatomical Ai | Change Healthcare Canada Company | 7/20/2021 | Radiology |
Powerlook Density Assessment Software V4.0 | Icad Inc. | 7/12/2021 | Radiology |
Pre-Sure | Lazarus, 3D, Inc | 7/8/2021 | Radiology |
Natural Cycles | Natural Cycles Nordic AB | 6/24/2021 | Obstetrics/Gynecology |
Codiagnostix | Dental Wings GmbH | 6/21/2021 | Dental |
LINQ II Insertable Cardiac Monitor, Zelda AI ECG Classification System | Medtronic, Inc. | 6/11/2021 | Cardiovascular |
Syngo.Via Mi Workflows, Scenium, Syngo Mbf | Siemens Medical Solutions Usa, Inc. | 6/10/2021 | Radiology |
Transpara 1.7.0 | Screenpoint Medical B.V. | 6/2/2021 | Radiology |
MEDO-Thyroid | Medo Dx Pte. Ltd. | 4/23/2021 | Radiology |
Preview Shoulder | Genesis Software Innovations | 4/21/2021 | Radiology |
Automatic Anatomy Recognition (AAR) | Quantitative Radiology Solutions, LLC | 4/20/2021 | Radiology |
DV.Target | Deepvoxel, Inc. | 4/2/2021 | Radiology |
syngo.CT Lung CAD (Version VD20) | Siemens Healthcare GmbH | 3/31/2021 | Radiology |
Oxehealth Vital Signs | Oxehealth Limited | 3/26/2021 | Cardiovascular |
Vbrain | Vysioneer Inc. | 3/19/2021 | Radiology |
Profound AI Software V3.0 | Icad Inc. | 3/12/2021 | Radiology |
Imbio RV/LV Software | Imbio, LLC | 3/9/2021 | Radiology |
Optellum Virtual Nodule Clinic, Optellum Software, Optellum Platform | Optellum Ltd | 3/5/2021 | Radiology |
Analytic For Hemodynamic Instability (Ahi) | Fifth Eye Inc. | 3/1/2021 | Cardiovascular |
SubtleMR | Subtle Medical, Inc. | 2/26/2021 | Radiology |
Cuptimize | Cuptimize, Inc. | 2/26/2021 | Radiology |
Truplan | Circle Cardiovascular Imaging Inc. | 2/19/2021 | Radiology |
Clue Birth Control | Biowink GmbH | 2/18/2021 | Obstetrics/Gynecology |
LVivo Software Application | Dia Imaging Analysis Ltd. | 2/5/2021 | Radiology |
Visage Breast Density | Visage Imaging GmbH | 1/29/2021 | Radiology |
Veuron-Brain-Pab | Heuron Co., Ltd. | 1/15/2021 | Radiology |
Art-Plan | Therapanacea | 1/14/2021 | Radiology |
Heartflow Analysis | Heartflow, Inc. | 1/8/2021 | Cardiovascular |
ImPACT Version 4 | ImPACT Applications, Inc. | 12/25/2020 | Neurology |
Planimax Orthodontic Software | Choice Biotech Inc. | 12/22/2020 | Dental |
EchoGo Pro | Ultromics Ltd. | 12/18/2020 | Radiology |
HepaFat-AI | Resonance Health Analysis Services Pty Ltd | 12/7/2020 | Radiology |
Genius Ai Detection | Hologic, Inc. | 11/18/2020 | Radiology |
Coroflow Cardiovascular System | Coroventis Research Ab | 11/13/2020 | Cardiovascular |
KardiaAI | Alivecor, Inc. | 11/12/2020 | Cardiovascular |
AI-Rad Companion Organs Rt | Siemens Medical Solutions Usa, Inc. | 11/6/2020 | Radiology |
Smart Alarm Interface | Boxview, LLC | 10/30/2020 | Cardiovascular |
Autocontour | Radformation, Inc. | 10/30/2020 | Radiology |
WRDensity by Whiterabbit.ai | Whiterabbit.Ai Inc. | 10/30/2020 | Radiology |
Aulisa Multiple Patient Digital Vital Sign Monitoring System | Taiwan Aulisa Medical Devices Technologies, Inc. | 10/30/2020 | Cardiovascular |
Stethee Pro 1, Stethee Pro Software System | M3Dicine Pty Ltd. | 10/9/2020 | Cardiovascular |
LVivo Seamless | Dia Imaging Analysis Ltd. | 9/29/2020 | Radiology |
Ventilator, Non-Continuous (Respirator) | Respironics, Inc. | 9/25/2020 | Anesthesiology |
Halo AF Detection System | Livmor | 9/23/2020 | Cardiovascular |
3Shape Implant Studio | 3Shape Medical A/S | 9/9/2020 | Radiology |
CER-S | Cardiocalm | 8/26/2020 | Cardiovascular |
Limbus Contour | Limbus Ai Inc. | 8/13/2020 | Radiology |
ECG Monitor App | Samsung Electronics Co., Ltd | 8/4/2020 | Cardiovascular |
AI-Rad Companion Prostate MR | Siemens Medical Solutions Usa Inc | 7/30/2020 | Radiology |
Fracturedetect (Fx) | Imagen Technologies, Inc. | 7/30/2020 | Radiology |
Caption Interpretation Automated Ejection Fraction Software | Caption Health | 7/22/2020 | Radiology |
Autolign | Diorco Co., Ltd. | 7/21/2020 | Dental |
Ezra Plexo Software | Ezra Ai Inc. | 7/10/2020 | Radiology |
Rapid LVO | iSchemaView Inc. | 7/9/2020 | Radiology |
Inferread Lung CT.AI | Beijing Infervision Technology Co.,Ltd. | 7/2/2020 | Radiology |
Contour ProtegeAI | Mim Software, Inc. | 7/2/2020 | Radiology |
Rapid Aspects | ISchemaView Inc. | 6/26/2020 | Radiology |
Lvivo Software Application | Dia Imaging Analysis Ltd | 6/23/2020 | Radiology |
Ulab Systems Udesign Software | Ulab Systems, Inc. | 6/23/2020 | Dental |
Quantib AI Node | Quantib BV | 6/15/2020 | Radiology |
uWS-MI | Shanghai United Imaging Healthcare Co., Ltd. | 6/11/2020 | Radiology |
MEDO ARIA | Medo.Ai | 6/11/2020 | Radiology |
Qlab Advanced Quantification Software | Philips Healthcare | 6/3/2020 | Radiology |
uWS-MR | Shanghai United Imaging Healthcare Co., Ltd | 6/1/2020 | Radiology |
Brainomix 360 E-CTA | Brainomix Limited | 5/28/2020 | Radiology |
Dibs (Digital Indirect Bonding System) | Orthoselect, LLC | 4/21/2020 | Dental |
BRUIS Software Suite | Mechanodontics, Inc. | 4/17/2020 | Dental |
Curarad-ICH | Curacloud Corp. | 4/13/2020 | Radiology |
Bluestar Rx | Welldoc, Inc | 4/7/2020 | Clinical Chemistry |
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. | 4/1/2020 | Radiology |
Arterys MICA | Arterys Inc. | 3/25/2020 | Radiology |
Mammoscreen | Therapixel | 3/25/2020 | Radiology |
Somryst | Pear Therapeutics, Inc. | 3/23/2020 | Neurology |
Syngo.Ct Lung Cad | Siemens Medical Solutions, Inc | 3/9/2020 | Radiology |
Transpara | Screenpoint Medical B.V. | 3/5/2020 | Radiology |
Broncholab | Fluidda Inc. | 3/4/2020 | Radiology |
AccuContour | Xiamen Manteia Technology Ltd. | 2/28/2020 | Radiology |
Ethos Treatment Management, Ethos Treatment Planning, Ethos Radiotherapy System, Halcyon | Varian Medical Systems, Inc. | 2/10/2020 | Radiology |
KardiaMobile, KardiaStation | Alivecor, Inc. | 1/24/2020 | Cardiovascular |
Qlab Advanced Quantification Software | Philips Healthcare | 12/20/2019 | Radiology |
Demetra BDEM-01 Dermatoscope | Barco Nv | 12/13/2019 | General & Plastic Surgery |
Transpara | Screenpoint Medical B.V. | 12/10/2019 | Radiology |
FFRangio | Cathworks Ltd | 12/9/2019 | Cardiovascular |
Blood Establishment Computer Software And Accessories | Terumo BCT, Inc | 12/3/2019 | Hematology |
Emprint Visualization Application | Covidien LLC. | 12/2/2019 | Radiology |
Hypotension Decision Assist | Directed Systems Ltd | 11/27/2019 | Cardiovascular |
Echogo Core | Ultromics Ltd. | 11/13/2019 | Radiology |
Medip Pro | Medicalip Co., Ltd | 11/7/2019 | Radiology |
Welldoc BlueStar | Welldoc, Inc. | 11/4/2019 | General Hospital |
Profound AI Software V2.1 | Icad Inc. | 10/4/2019 | Radiology |
Asthma Monitor AM3 | eResearchTechnology | 10/3/2019 | Anesthesiology |
RTapp | Segana, LLC | 10/1/2019 | Radiology |
Stonechecker | Imaging Biometrics, LLC | 9/26/2019 | Radiology |
SubtleMR | Subtle Medical, Inc. | 9/16/2019 | Radiology |
Biovitals Analytics Engine | Biofourmis Singapore Pte. Ltd | 8/15/2019 | Cardiovascular |
HeartfFow FFRct Analysis | Heartflow, Inc. | 8/15/2019 | Cardiovascular |
Sleepimage System | Mycardio, LLC DBA Sleepimage | 8/14/2019 | Anesthesiology |
Drowzle | Resonea, Inc. | 7/14/2019 | Anesthesiology |
Koios DS For Breast | Koios Medical, Inc. | 7/3/2019 | Radiology |
uWS-CT | Shanghai United Imaging Healthcare Co., Ltd. | 6/24/2019 | Radiology |
uWS-MR | Shanghai United Imaging Healthcare Co., Ltd. | 3/22/2019 | Radiology |
KardiaAI | Alivecor, Inc. | 3/11/2019 | Cardiovascular |
DTX Studio design | Nobel Biocare AB | 3/1/2019 | Dental |
Myostrain 5.1 | Myocardial Solutions | 2/14/2019 | Radiology |
Zoll ECG Analysis Software | Zoll Manufacturing Corporation | 1/28/2019 | Cardiovascular |
FFRangio System | Cathworks Ltd | 12/19/2018 | Cardiovascular |
Hipcheck | Stryker Corp. | 12/13/2018 | Radiology |
FFRct v2.18 | Heartflow, Inc. | 12/6/2018 | Cardiovascular |
Powerlook Tomo Detection V2 Software | Icad Inc. | 12/6/2018 | Radiology |
CAAS Mr Solutions | Pie Medical Imaging B.V. | 12/4/2018 | Radiology |
Ferrismart Analysis System | Resonance Health Analysis Services Pty Ltd | 11/30/2018 | Radiology |
Orchestrate 3D | Orchestrate 3D | 11/26/2018 | Dental |
Transpara | Screenpoint Medical Bv | 11/21/2018 | Radiology |
Blood Establishment Computer Software And Accessories | Data Innovations LLC | 11/8/2018 | Hematology |
uWS-MR | Shanghai United Imaging Healthcare Co.,Ltd. | 11/7/2018 | Radiology |
uWS-CT | Shanghai United Imaging Healthcare Co.,Ltd. | 11/7/2018 | Radiology |
ImPACT | ImPACT Applications, Inc. | 10/20/2018 | Neurology |
mediCAD 4.0 | MediCAD Hectec GmbH | 9/7/2018 | Radiology |
IGTFusion | Igi Technologies | 8/16/2018 | Radiology |
Quantitative Total Extensible Imaging (QTxI) | AIQ Solutions, Inc. | 7/23/2018 | Radiology |
Workflow Box | Mirada Medical Ltd. | 7/10/2018 | Radiology |
Blood Establishment Computer Software And Accessories | Mediware Information Systems, Inc. | 7/3/2018 | Hematology |
Vios Monitoring System™ Model 2050 | Vios Medical, Inc. | 6/22/2018 | Cardiovascular |
OsteoDetect | Imagen Technologies, Inc. | 5/24/2018 | Radiology |
CAAS Workstation | Pie Medical Imaging BV | 5/3/2018 | Radiology |
Encevis | Ait Austrian Institute Of Technology Gmbh | 4/19/2018 | Neurology |
uWS-MI | Shanghai United Imaging Healthcare Co.,Ltd. | 4/5/2018 | Radiology |
Simplant 18 | Dentsply Sirona | 4/4/2018 | Radiology |
Emprint Ablation Visualization Application | Covidien, LLC | 3/21/2018 | Radiology |
Cerec Ortho Software | Dentsply Sirona | 1/11/2018 | Dental |
ULab Systems Treatment Planning Software | ULab Systems, Inc. | 1/9/2018 | Dental |
Neuronaute | Bioserenity | 12/26/2017 | Neurology |
jFit Surgical Planner | JointVue LLC | 11/15/2017 | Radiology |
SurgicalPreview | Endo Vantage, LLC | 11/8/2017 | Cardiovascular |
CSMC Cardiac Suite | Cedars-Sinai Medical Center | 11/3/2017 | Radiology |
LINACwatch, LinacView | Qualiformed Sarl | 10/27/2017 | Radiology |
Endonaut | Therenva Sas | 9/21/2017 | Radiology |
Tremoflo C-100 Airwave Oscillometry System | Thorasys Thoracic Medical Systems, Inc. | 9/12/2017 | Anesthesiology |
Quantx | Quantitative Insights, Inc | 7/19/2017 | Radiology |
3D Endo Software | Dentsply Sirona | 7/17/2017 | Radiology |
ImPACT Quick Test | ImPACT Applications, Inc. | 6/21/2017 | Neurology |
Sonosite X-Porte Ultrasound System | Fujifilm Sonosite, Inc. | 6/12/2017 | Radiology |
Move Forward 3D Motion Simulation Service | Biomet Inc. | 3/31/2017 | Radiology |
EnsoSleep | Ensodata, Inc. | 3/31/2017 | Neurology |
ImPACT | ImPACT Applications, Inc. | 2/23/2017 | Neurology |
Welldoc BlueStar, Welldoc BlueStar Rx | Welldoc, Inc | 1/12/2017 | General Hospital |
Go Dose System | Eli Lilly And Company | 12/22/2016 | General Hospital |
CAAS Mr 4D Flow | Pie Medical Imaging B.V. | 12/8/2016 | Radiology |
CuattroDR | Cuattro, LLC | 10/6/2016 | Radiology |
Blood Establishment Computer Software And Accessories | Mediware Information Systems, Inc. | 9/30/2016 | Hematology |
ClearRead CT | Riverain Technologies, LLC | 9/9/2016 | Radiology |
ResolutionMD | Calgary Scientific, Inc. | 8/24/2016 | Radiology |
FFRct v2.0 | Heartflow, Inc. | 8/24/2016 | Cardiovascular |
SonoSite SII Ultrasound System, SonoSite Edge II Ultrasound System | Fujifilm Sonosite, Inc. | 8/18/2016 | Radiology |
Kuvia3D | 4Qimaging, LLC DBA Qmetrics | 6/23/2016 | Radiology |
EndoSize | Therenva Sas | 4/12/2016 | Radiology |
Sentinel Cardiology Information Management System | Spacelabs Healthcare Ltd. | 4/1/2016 | Cardiovascular |
Adaptivo | Aurora Technology Development, LLC | 2/3/2016 | Radiology |
FFRct | Heartflow, Inc. | 1/13/2016 | Cardiovascular |
ImplantMax Software | Saturn Imaging Inc. | 1/12/2016 | Radiology |
syngo VSim | Siemens Medical Solutions Usa, Inc. | 9/16/2015 | Radiology |
QuickPlan | Siris Medical | 9/11/2015 | Radiology |
CS 3D Imaging | Trophy | 8/19/2015 | Radiology |
Personalized Physiology Analytics Engine Software | Vgbio, Inc. (DBA Physiq) | 6/11/2015 | Cardiovascular |
AWARE | Ambient Clinical Analytics | 4/2/2015 | Cardiovascular |
CAAS A-Valve | Pie Medical Imaging B.V. | 2/6/2015 | Radiology |
IPACS Medical Image Management System | Visbion Limited | 12/12/2014 | Radiology |
Varia-NCI | Neurochaos Solutions, Inc. | 11/19/2014 | Radiology |
Emprint Procedure Planning Application | Covidien LLC | 9/17/2014 | Radiology |
EndoSize | Therenva Sas | 7/31/2014 | Radiology |
Cedars-Sinai Cardiac Suite Nuclear Medicine Software | Cedars-Sinai Medical Center | 7/22/2014 | Radiology |
mediCAD Classic | Hectec GmbH | 6/5/2014 | Radiology |
SonoSite Edge Ultrasound System | Fujifilm Sonosite,Inc. | 12/16/2013 | Radiology |
HepaFat Scan | Resonance Health Analysis Services Pty Ltd | 12/13/2013 | Radiology |
M-Vu Breast Density | Vucomp, Inc. | 12/3/2013 | Radiology |
DYONICS PLAN Hip Impingement Planning System | Smith & Nephew, Inc. | 10/17/2013 | Radiology |
CorView | Marrek, Inc | 8/21/2013 | Radiology |
Freestyle Auto-Assist Software Version 2.0 with Model PRT24238-001 | Abbott Laboratories | 4/5/2013 | Clinical Chemistry |
CAAS IntraVascular | Pie Medical Imaging B.V. | 2/6/2013 | Radiology |
OnQ rts | Oncology Systems, Inc. | 12/28/2012 | Radiology |
EchoSoft(TM) | Echometrix LLC | 9/21/2012 | Radiology |
Blood Establishment Computer Software And Accessories | Mediware Information Systems, Inc. | 9/19/2012 | Hematology |
VirtuOst | O.N. Diagnostics | 9/13/2012 | Radiology |
Blood Establishment Computer Software And Accessories | Mediware Information Systems, Inc. | 9/5/2012 | Hematology |
DynaPBV Body Software | Siemens Medical Solutions Usa, Inc. | 7/30/2012 | Radiology |
NERVEVISION Software Systems | 3D Imaging Partners Inc. | 7/26/2012 | Radiology |
Praezis Plus | Tatramed Spol. S.R.O. | 5/24/2012 | Neurology |
3mensio Workstation | Pie Medical Imaging B.V. | 4/17/2012 | Radiology |
CAAS A-Valve | Pie Medical Imaging B.V. | 1/30/2012 | Radiology |
Swissmeda Dental Planning System | Swissmeda AG | 1/25/2012 | Radiology |
Metron-CP/MD | Eponatech LLC | 12/20/2011 | Radiology |
syngo Aortic ValveGuide Software | Siemens Medical Solutions Usa, Inc. | 11/22/2011 | Radiology |
MRI-Q System | Resonance Health Analysis Services Pty Ltd | 7/28/2011 | Radiology |
CSMC Cardiac Suite-Nuclear Medicine Software Application Model 2010-01 | Cedars-Sinai Medical Center | 4/1/2011 | Radiology |
SpineAnalyer Model SAPOC | Optasia Medical | 1/5/2011 | Radiology |
Blood Establishment Computer Software And Accessories | Mediware Information Systems, Inc. | 11/16/2010 | Hematology |
FulAccess Model 1.0 | Fulcrum Medical, Inc | 10/29/2010 | Radiology |
GE EchoPac Model BT10 | Ge Vingmed Ultrasound As | 10/5/2010 | Radiology |
Illumina BeadXpress System | Illumina, Inc. | 4/28/2010 | Hematology |
Diagnosoft HARP Model 2.06 | Diagnosoft, Inc. | 3/11/2010 | Radiology |
Dose Volume Histogram (DVH) Evaluator | Diversilabs, LLC | 12/16/2009 | Radiology |
PMD Viewer | Spencer Technologies | 10/8/2009 | Radiology |
GE Innova Solid State X-Ray-Imager Fluoroscopic X-Ray System, Model: 4100IQ, 3100IQ, 2100IQ | GE Healthcare | 8/25/2009 | Radiology |
RayAutoPlan 1.0 | Raysearch Laboratories AB | 1/22/2009 | Radiology |
Visage PACS, Version 6.0/CS 3.1 | Visage Imaging, Inc. | 12/12/2008 | Radiology |
Standard Imaging IMSure Brachy QA Software, Model 91331 | Standard Imaging, Inc. | 11/19/2008 | Radiology |
bp Limbo XL, bp Tango XL, bp Salsa XL | DataDancer Medical Systems | 10/31/2008 | Cardiovascular |
OsDx Hip BMD System | Imaging Therapeutics, Inc. | 10/16/2008 | Radiology |
VelocityAIS, Velocity AI, VelocityVX, VelocityRT, V-Response | Velocity Medical Solutions, LLC | 6/20/2008 | Radiology |
OneTouch Zoom Diabetes Management Program | Lifescan, Inc. | 6/9/2008 | Clinical Chemistry |
Blood Establishment Computer Software And Accessories | Mak-System | 5/13/2008 | Hematology |
CMRtools and Plug-Ins Ventricular Tools & Thalassaemia Tools | Cardiovascular Imaging Solutions Ltd. | 2/14/2008 | Radiology |
Modification to: BPCard, Model Z-7000-0700 | Qrs Diagnostic, LLC | 1/11/2008 | Cardiovascular |
Blood Establishment Computer Software And Accessories | Mak-System | 10/26/2007 | Hematology |
Clarian Glucose Stabilizer Insulin Dosing Calculator | Medical Decisions Network | 10/12/2007 | General Hospital |
MIM 4.1 (SEASTAR) | Mimvista Corp. | 9/26/2007 | Radiology |
Visage PACS/CS, Release Version 5.0 | Mercury Computer Systems, Inc | 8/29/2007 | Radiology |
Xebra DICOM Image Browser | Hx Technologies, Inc. | 8/16/2007 | Radiology |
Blood Establishment Computer Software And Accessories | Mak-System | 5/9/2007 | Hematology |
Blood Establishment Computer Software And Accessories | Prescott Ideas LLC | 4/23/2007 | Hematology |
VelocityAIS | Velocity Medical Solutions, LLC | 3/1/2007 | Radiology |
Aegis | Sentinelle Medical, Inc. | 2/9/2007 | Radiology |
ToPACS | Radiological Specialists, Inc. | 1/24/2007 | Radiology |
Visage PACS/CS, Release Version 4.1 | Mercury Computer Systems, Inc | 10/27/2006 | Radiology |
Diagnosoft HARP | Diagnosoft, Inc. | 7/28/2006 | Radiology |
VISTADENT AT COMPLETE, Model 3.1 | Dentsply Intl., Inc. | 11/22/2005 | Radiology |
Hipax Medical Imaging Software | Steinhart Medizinsysteme Gmbh | 9/21/2005 | Radiology |
OPD-Station Software | Nidek, Inc. | 8/24/2005 | Ophthalmic |
RADIN, Model V 3.0 | Sohard Ag | 1/28/2005 | Radiology |
Vascular Tools 5, Consisting Of Brachial Analyzer 5, Carotid Analyzer 5, Vascular Imager 5 and Integrated Vascular Tools | Medical Imaging Applications LLC | 12/16/2004 | Cardiovascular |
MIStar, Model V3.2 | Apollo Medical Imaging Technology Pty Ltd. | 12/15/2004 | Radiology |
Standard Imaging PIPSpro QA Software System | Standard Imaging, Inc. | 11/15/2004 | Radiology |
RSA-CMS | Medis Medical Imaging Systems, B.V. | 10/20/2004 | Radiology |
Ortho-CMS | Medis Medical Imaging Systems, B.V. | 7/27/2004 | Radiology |
ComPACS, Version 1.0 | Intelligent Images Srl | 6/22/2004 | Radiology |
MRA-CMS | Medis Medical Imaging Systems, B.V. | 6/8/2004 | Radiology |
Standard Imaging E.IMRT Calculator | Standard Imaging, Inc. | 5/11/2004 | Radiology |
CT-Mass | Medis Medical Imaging Systems, B.V. | 3/2/2004 | Radiology |
Orthopacs | Etrauma.Com Corp. | 2/2/2004 | Radiology |
Modification To Wackers-Liu CQ Software | Eclipse Systems, Inc. | 8/25/2003 | Radiology |
Ramsoft Pacs, Model 3.0 | Ramsoft, Inc. | 8/11/2003 | Radiology |
Quantitative Vascular Angiography – CMS | Medis Medical Imaging Systems, B.V. | 1/24/2003 | Radiology |
Autoalign | Cortechs Labs, Inc. | 7/12/2002 | Radiology |
eFilm Workstation with Modules | Efilm Medical, Inc. | 4/12/2002 | Radiology |
Opus Spectrum (A Model Of Opus 20), Model 2nd | Opusdent Ltd. | 1/8/2002 | General & Plastic Surgery |
QCU Analytical Software Package | Medis Medical Imaging Systems, B.V. | 7/31/2001 | Radiology |
eFilm Workstation | Efilm Medical, Inc. | 7/31/2001 | Radiology |
MRI- Magnetic Resonance Analytical Software System | Medis Medical Imaging Systems, B.V. | 8/30/2000 | Radiology |
Prosolv Echoviewer, Prosolv Echoviewer Se, Prosolv Echoanalyzer, Prosolv Echoserv, Prosolv Echo | Problem Solving Concepts, Inc. | 2/2/2000 | Radiology |
Cardiovascular Measurement System – View | Medis Medical Imaging Systems, B.V. | 12/28/1999 | Radiology |
Quantitative Analysis Of Coronary Angiograms (Qca) | Medis Medical Imaging Systems, B.V. | 11/26/1999 | Radiology |
Quantitative Analysis Of Left Ventricular Angiograms (Qlv) | Medis Medical Imaging Systems, B.V. | 11/26/1999 | Radiology |
Itr2000: Internet Teleradiology, Model Release 1.0 | Inteleradiology, Inc. | 9/29/1999 | Radiology |
Vox/Base For Windows | J-Mac System, Inc. | 10/27/1997 | Radiology |
Radworks Medical Imaging Software | Applicare Medical Imaging, B.V. | 8/19/1996 | Radiology |
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