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FDA-listed AI/ML-enabled medical devices

Devices the FDA identifies as using artificial intelligence or machine learning, with the regulators each one is registered with.

1,255 devices · when each source was last refreshed

Registers: US (FDA) · UK (MHRA) · CA (Health Canada) · AU (TGA) · EU (EUDAMED)

Device
Vantage Galan 3T, MRT-3020, V9.0 with AiCE Reconstruction Processing Unit for MR

Canon Medical Systems Corporation

Registered with
  • US (FDA)
Vantage Orian 1.5T, MRT-1550, V6.0

Canon Medical Systems Corporation

Registered with
  • US (FDA)
Vantage Orian 1.5T, MRT-1550, V6.0 with AiCE Reconstruction Processing Unit for MR

Canon Medical Systems Corporation

Registered with
  • US (FDA)
vascuCAP

Elucid Bioimaging, Inc.

Registered with
  • US (FDA)
VBrain

Vysioneer, Inc.

Registered with
  • US (FDA)
VBrain-OAR

Vysioneer, Inc.

Registered with
  • US (FDA)
VEA Align

Eos Imaging

Registered with
  • US (FDA)
  • UK (MHRA)
  • EU (EUDAMED)
VEA Align; spineEOS

Eos Imaging

Registered with
  • US (FDA)
Velacur

Sonic Incytes

Registered with
  • US (FDA)
VELMENI for DENTISTS(V4D)

Velmeni, Inc.

Registered with
  • US (FDA)
  • UK (MHRA)
  • EU (EUDAMED)
VELYS™ Hip Navigation

Depuy Ireland UC

Registered with
  • US (FDA)
Vent Creativity Knee v1.0 (Hermes)

Vent Creativity

Registered with
  • US (FDA)
Ventripoint Medical System Plus (VMS+)

Ventripoint Diagnostics , Ltd.

Registered with
  • US (FDA)
  • EU (EUDAMED)
Ventripoint Medical System Plus (VMS+) 3.0

Ventripoint Diagnostics , Ltd.

Registered with
  • US (FDA)
Ventripoint Medical System Plus (VMS+) 4.0

Ventripoint Diagnostics , Ltd.

Registered with
  • US (FDA)
Venue

Ge Medical Systems, Inc.

Registered with
  • US (FDA)
Venue

GE Medical Systems Ultrasound and Primary Care Diagnostics, LLC

Registered with
  • US (FDA)
  • UK (MHRA)
  • Canada (Health Canada)
  • EU (EUDAMED)
Venue Fit

Ge Medical Systems, Inc.

Registered with
  • US (FDA)
Venue Go

GE Medical Systems Ultrasound and Primary Care Diagnostics, LLC

Registered with
  • US (FDA)
  • UK (MHRA)
  • Canada (Health Canada)
  • EU (EUDAMED)
Venue; Venue Go; Venue Fit; Venue Sprint

GE Medical Systems Ultrasound and Primary Care Diagnostics, LLC

Registered with
  • US (FDA)
Vereos PET/CT

Philips Medical Systems Nederland BV

Registered with
  • US (FDA)
  • Canada (Health Canada)
  • EU (EUDAMED)
VERITON CT 300 Series Digital SPECT/CT System (VERITON CT 316/364); VERITON CT 400 Series Digital SPECT/CT System (VERITON CT 416/464)

Spectrum Dynamics Medical, Ltd.

Registered with
  • US (FDA)
Versana Balance

GE Medical Systems Ultrasound and Primary Care Diagnostics, LLC

Registered with
  • US (FDA)
Versana Premier

GE Medical Systems Ultrasound and Primary Care Diagnostics, LLC

Registered with
  • US (FDA)
Versana Premier; Versana Premier Lotus; LOGIQ F

GE Medical Systems Ultrasound and Primary Care Diagnostics, LLC

Registered with
  • US (FDA)
VersaViewer

Ge Medical Systems Scs

Registered with
  • US (FDA)
  • UK (MHRA)
  • EU (EUDAMED)
Veuron-Brain-pAb3

Heuron Co., Ltd.

Registered with
  • US (FDA)
VIDAvision

VIDA DIAGNOSTICS, INC.

Registered with
  • US (FDA)
Videa Caries Assist

Videahealth, Inc.

Registered with
  • US (FDA)
Videa Dental AI

Videahealth, Inc.

Registered with
  • US (FDA)
  • UK (MHRA)
Videa Dental Assist

Videahealth, Inc.

Registered with
  • US (FDA)
Videa Perio Assist

Videahealth, Inc.

Registered with
  • US (FDA)
  • UK (MHRA)
ViewFinder Software Version 1.1

Elaitra

Registered with
  • US (FDA)
VinDr-Mammo

Vinbigdata Joint Stock Company

Registered with
  • US (FDA)
VisAble.IO

Techsomed

Registered with
  • US (FDA)
Visage Breast Density

Visage Imaging, Inc.

Registered with
  • US (FDA)
  • UK (MHRA)
  • Canada (Health Canada)
  • AU (TGA)
  • EU (EUDAMED)
VISENSIA

Obs Medical

Registered with
  • US (FDA)
  • UK (MHRA)
  • Canada (Health Canada)
VISIONAIR

Pacificmd Biotech, LLC

Registered with
  • US (FDA)
VisiRad XR

Imidex, Inc.

Registered with
  • US (FDA)
Vista OS, Vista AI Scan, RTHawk

Vista Ai, Inc.

Registered with
  • US (FDA)
VitalRhythm

Vitalconnect, Inc.

Registered with
  • US (FDA)
Vital Signs

Oxehealth Limited

Registered with
  • US (FDA)
  • UK (MHRA)
  • EU (EUDAMED)
VITEK MS

bioMérieux SA

Registered with
  • US (FDA)
  • UK (MHRA)
Vitrea CT Brain Perfusion

Vital Images, Inc.

Registered with
  • US (FDA)
Vivid E80/ Vivid E90/ Vivid E95

Ge Medical Systems Ultrasound And

Registered with
  • US (FDA)
Vivid E80, Vivid E90, Vivid E95

GE Medical Systems Ultrasound and Primary Care Diagnostics, LLC

Registered with
  • US (FDA)
Vivid iq

GE Medical Systems Ultrasound and Primary Care Diagnostics, LLC

Registered with
  • US (FDA)
Vivid iq

Ge Medical Systems Ultrasound And

Registered with
  • US (FDA)
Vivid Pioneer

GE Medical Systems Ultrasound and Primary Care Diagnostics, LLC

Registered with
  • US (FDA)
Vivid S60N, Vivid S70N

GE Medical Systems Ultrasound and Primary Care Diagnostics, LLC

Registered with
  • US (FDA)