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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.

1,330 devices · when each source was last refreshed

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

Device
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)
Vitrea CT Transcatheter Aortic Valve Replacement (TAVR) Planning

Canon Medical Informatics 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)
Vivid T8, Vivid T9

GE Medical Systems Ultrasound and Primary Care Diagnostics, LLC

Registered with
  • US (FDA)
Vivid T9/Vivid T8

GE Medical Systems Ultrasound and Primary Care Diagnostics, LLC

Registered with
  • US (FDA)
Vivio® LVEDP System

Avicena, LLC

Registered with
  • US (FDA)
Viz AAA

Viz. Ai, Inc.

Registered with
  • US (FDA)
Viz ANEURYSM, Viz ANX

Viz. Ai, Inc.

Registered with
  • US (FDA)
Viz CTP

Viz. Ai, Inc.

Registered with
  • US (FDA)
  • EU (EUDAMED)
Viz HCM

Viz. Ai, Inc.

Registered with
  • US (FDA)
Viz HDS, Viz Volume Plus, Viz ICH+

Viz. Ai, Inc.

Registered with
  • US (FDA)
Viz ICH

Viz. Ai, Inc.

Registered with
  • US (FDA)
  • EU (EUDAMED)
Viz LVO ContaCT

Viz. Ai, Inc.

Registered with
  • US (FDA)
Viz RV/LV

Viz. Ai, Inc.

Registered with
  • US (FDA)
Viz SDH

Viz. Ai, Inc.

Registered with
  • US (FDA)
Viz Subdural+, Viz SUBDURAL PLUS

Viz. Ai, Inc.

Registered with
  • US (FDA)
Volpara Imaging Software

LUNIT INTERNATIONAL LIMITED

Registered with
  • US (FDA)
  • Canada (Health Canada)
Volpara Imaging Software

Matakina Technology Limited

Registered with
  • US (FDA)
Volta AF-Xplorer

Volta Medical

Registered with
  • US (FDA)
Volta AF-Xplorer II

Volta Medical

Registered with
  • US (FDA)
Voluson Expert 18; Voluson Expert 20; Voluson Expert 22

GE Medical Systems Ultrasound and Primary Care Diagnostics, LLC

Registered with
  • US (FDA)
Voluson Expert 22, Voluson Expert 20, Voluson Expert 18

GE Medical Systems Ultrasound and Primary Care Diagnostics, LLC

Registered with
  • US (FDA)
VOLUSON P6, VOLUSON P8

Ge Healthcare

Registered with
  • US (FDA)
Voluson™ Performance 16; Voluson™ Performance 18

GE Medical Systems Ultrasound and Primary Care Diagnostics, LLC

Registered with
  • US (FDA)
Voluson S6, Voluson S8, Voluson S8t, Voluson S10, Voluson S10 Expert

Ge Healthcare

Registered with
  • US (FDA)
Voluson Signature 20, Voluson Signature 18

GE Medical Systems Ultrasound and Primary Care Diagnostics, LLC

Registered with
  • US (FDA)
Voluson SWIFT; Voluson SWIFT+

Ge Medical Systems Ultrasound & Primary Care Diagnostic, LLC

Registered with
  • US (FDA)
Voxel Dosimetry (00859873006226)

Hermes Medical Solutions AB

Registered with
  • US (FDA)
Vscan Air

GE Medical Systems Ultrasound and Primary Care Diagnostics, LLC

Registered with
  • US (FDA)
VUNO Med-Chest X-ray Triage/VUNO Med-CXR Link Triage

VUNO INC

Registered with
  • US (FDA)