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	Manufacturer	US	UK	CA	AU	EU
Us2.v2 Eko.Ai Pte Ltd. D/B/A Us2.Ai Registered with US (FDA)	Eko.Ai Pte Ltd. D/B/A Us2.Ai	Registered with US (FDA)	Not registered with UK (MHRA)	Not registered with Canada (Health Canada)	Not registered with AU (TGA)	Not registered with EU (EUDAMED)
Uscan EchoNous, Inc Registered with US (FDA)	EchoNous, Inc	Registered with US (FDA)	Not registered with UK (MHRA)	Not registered with Canada (Health Canada)	Not registered with AU (TGA)	Not registered with EU (EUDAMED)
uSONIQUE Genesis, uSONIQUE Genesis Pro, uSONIQUE Genesis Elite, uSONIQUE Genesis Super, uSONIQUE Pulse, uSONIQUE Pulse Pro, uSONIQUE Pulse Elite, uSONIQUE Pulse Super, uSONIQUE Venus, uSONIQUE Venus Pro, uSONIQUE Venus Elite, uSONIQUE Venus Super Wuhan United Imaging Healthcare Co., Ltd. Registered with US (FDA)	Wuhan United Imaging Healthcare Co., Ltd.	Registered with US (FDA)	Not registered with UK (MHRA)	Not registered with Canada (Health Canada)	Not registered with AU (TGA)	Not registered with EU (EUDAMED)
uSONIQUE Nova, uSONIQUE Nova Elite, uSONIQUE Vita, uSONIQUE Vita Elite, uSONIQUE Grace, uSONIQUE Grace Elite Wuhan United Imaging Healthcare Co., Ltd. Registered with US (FDA)	Wuhan United Imaging Healthcare Co., Ltd.	Registered with US (FDA)	Not registered with UK (MHRA)	Not registered with Canada (Health Canada)	Not registered with AU (TGA)	Not registered with EU (EUDAMED)
uWS-MR Shanghai United Imaging Healthcare Co., Ltd. Registered with US (FDA)	Shanghai United Imaging Healthcare Co., Ltd.	Registered with US (FDA)	Not registered with UK (MHRA)	Not registered with Canada (Health Canada)	Not registered with AU (TGA)	Not registered with EU (EUDAMED)
V5 Diagnostic Ultrasound System, H5 Diagnostic Ultrasound System, XV5 Diagnostic Ultrasound System, XH5 Diagnostic Ultrasound System, V4 Diagnostic Ultrasound System, H4 Diagnostic Ultrasound System, XV4 Diagnostic Ultrasound System, XH4 Diagnostic Ultrasound System Samsung Medison Co., Ltd. Registered with US (FDA)	Samsung Medison Co., Ltd.	Registered with US (FDA)	Not registered with UK (MHRA)	Not registered with Canada (Health Canada)	Not registered with AU (TGA)	Not registered with EU (EUDAMED)
V5med Lung AI V5med, Inc. Registered with US (FDA)	V5med, Inc.	Registered with US (FDA)	Not registered with UK (MHRA)	Not registered with Canada (Health Canada)	Not registered with AU (TGA)	Not registered with EU (EUDAMED)
V8 Diagnostic Ultrasound System Samsung Medison Co., Ltd. Registered with US (FDA) Canada (Health Canada)	Samsung Medison Co., Ltd.	Registered with US (FDA)	Not registered with UK (MHRA)	Registered with Canada (Health Canada)	Not registered with AU (TGA)	Not registered with EU (EUDAMED)
V8 Diagnostic Ultrasound System; cV8 Diagnostic Ultrasound System; V7 Diagnostic Ultrasound System; cV7 Diagnostic Ultrasound System; V6 Diagnostic Ultrasound System; cV6 Diagnostic Ultrasound System Samsung Medison Co., Ltd. Registered with US (FDA)	Samsung Medison Co., Ltd.	Registered with US (FDA)	Not registered with UK (MHRA)	Not registered with Canada (Health Canada)	Not registered with AU (TGA)	Not registered with EU (EUDAMED)
V8 Diagnostic Ultrasound System; cV8 Diagnostic Ultrasound System; V7 Diagnostic Ultrasound System; cV7 Diagnostic Ultrasound System; V6 Diagnostic Ultrasound System; cV6 Diagnostic Ultrasound System; V5 Diagnostic Ultrasound System; cV5 Diagnostic Ultrasound System; V4 Diagnostic Ultrasound System; cV4 Diagnostic Ultrasound System Samsung Medison Co., Ltd. Registered with US (FDA)	Samsung Medison Co., Ltd.	Registered with US (FDA)	Not registered with UK (MHRA)	Not registered with Canada (Health Canada)	Not registered with AU (TGA)	Not registered with EU (EUDAMED)
V8 Diagnostic Ultrasound System, V7 Diagnostic Ultrasound System Samsung Medison Co., Ltd. Registered with US (FDA)	Samsung Medison Co., Ltd.	Registered with US (FDA)	Not registered with UK (MHRA)	Not registered with Canada (Health Canada)	Not registered with AU (TGA)	Not registered with EU (EUDAMED)
V8/H8 Diagnostic Ultrasound System, V7/H7 Diagnostic Ultrasound System, V6/H6 Diagnostic Ultrasound System Samsung Medison Co., Ltd. Registered with US (FDA)	Samsung Medison Co., Ltd.	Registered with US (FDA)	Not registered with UK (MHRA)	Not registered with Canada (Health Canada)	Not registered with AU (TGA)	Not registered with EU (EUDAMED)
V8/XV8/XH8, V7/XV7/XH7, V6/XV6/XH6 Diagnostic Ultrasound System Samsung Medison Co., Ltd. Registered with US (FDA)	Samsung Medison Co., Ltd.	Registered with US (FDA)	Not registered with UK (MHRA)	Not registered with Canada (Health Canada)	Not registered with AU (TGA)	Not registered with EU (EUDAMED)
Vantage Fortian 1.5T, MRT-1550, V8.0 with AiCE Reconstruction Processing Unit for MR Canon Medical Systems Corporation Registered with US (FDA)	Canon Medical Systems Corporation	Registered with US (FDA)	Not registered with UK (MHRA)	Not registered with Canada (Health Canada)	Not registered with AU (TGA)	Not registered with EU (EUDAMED)
Vantage Fortian/Orian 1.5T, MRT-1550, V10.0 with AiCE Reconstruction Processing Unit for MR Canon Medical Systems Corporation Registered with US (FDA)	Canon Medical Systems Corporation	Registered with US (FDA)	Not registered with UK (MHRA)	Not registered with Canada (Health Canada)	Not registered with AU (TGA)	Not registered with EU (EUDAMED)
Vantage Fortian/Orian 1.5T, MRT-1550, V9.0 with AiCE Reconstruction Processing Unit for MR Canon Medical Systems Corporation Registered with US (FDA)	Canon Medical Systems Corporation	Registered with US (FDA)	Not registered with UK (MHRA)	Not registered with Canada (Health Canada)	Not registered with AU (TGA)	Not registered with EU (EUDAMED)
Vantage Galan 3T, MRT-3020, V10.0 with AiCE Reconstruction Processing Unit for MR Canon Medical Systems Corporation Registered with US (FDA)	Canon Medical Systems Corporation	Registered with US (FDA)	Not registered with UK (MHRA)	Not registered with Canada (Health Canada)	Not registered with AU (TGA)	Not registered with EU (EUDAMED)
Vantage Galan 3T, MRT-3020, V6.0 with AiCE Reconstruction Processing Unit for MR Canon Medical Systems Corporation Registered with US (FDA)	Canon Medical Systems Corporation	Registered with US (FDA)	Not registered with UK (MHRA)	Not registered with Canada (Health Canada)	Not registered with AU (TGA)	Not registered with EU (EUDAMED)
Vantage Galan 3T, MRT-3020, V8.0 with AiCE Reconstruction Processing Unit for MR Canon Medical Systems Corporation Registered with US (FDA)	Canon Medical Systems Corporation	Registered with US (FDA)	Not registered with UK (MHRA)	Not registered with Canada (Health Canada)	Not registered with AU (TGA)	Not registered with EU (EUDAMED)
Vantage Galan 3T, MRT-3020, V9.0 with AiCE Reconstruction Processing Unit for MR Canon Medical Systems Corporation Registered with US (FDA)	Canon Medical Systems Corporation	Registered with US (FDA)	Not registered with UK (MHRA)	Not registered with Canada (Health Canada)	Not registered with AU (TGA)	Not registered with EU (EUDAMED)
Vantage Orian 1.5T, MRT-1550, V6.0 Canon Medical Systems Corporation Registered with US (FDA)	Canon Medical Systems Corporation	Registered with US (FDA)	Not registered with UK (MHRA)	Not registered with Canada (Health Canada)	Not registered with AU (TGA)	Not registered with EU (EUDAMED)
Vantage Orian 1.5T, MRT-1550, V6.0 with AiCE Reconstruction Processing Unit for MR Canon Medical Systems Corporation Registered with US (FDA)	Canon Medical Systems Corporation	Registered with US (FDA)	Not registered with UK (MHRA)	Not registered with Canada (Health Canada)	Not registered with AU (TGA)	Not registered with EU (EUDAMED)
vascuCAP Elucid Bioimaging, Inc. Registered with US (FDA)	Elucid Bioimaging, Inc.	Registered with US (FDA)	Not registered with UK (MHRA)	Not registered with Canada (Health Canada)	Not registered with AU (TGA)	Not registered with EU (EUDAMED)
Vascular Assist Occlusion Triage (VAOT) (v1.0) GuideAI Health Registered with US (FDA)	GuideAI Health	Registered with US (FDA)	Not registered with UK (MHRA)	Not registered with Canada (Health Canada)	Not registered with AU (TGA)	Not registered with EU (EUDAMED)
VBrain Vysioneer, Inc. Registered with US (FDA)	Vysioneer, Inc.	Registered with US (FDA)	Not registered with UK (MHRA)	Not registered with Canada (Health Canada)	Not registered with AU (TGA)	Not registered with EU (EUDAMED)
VBrain-OAR Vysioneer, Inc. Registered with US (FDA)	Vysioneer, Inc.	Registered with US (FDA)	Not registered with UK (MHRA)	Not registered with Canada (Health Canada)	Not registered with AU (TGA)	Not registered with EU (EUDAMED)
VEA Align Eos Imaging Registered with US (FDA) UK (MHRA) EU (EUDAMED)	Eos Imaging	Registered with US (FDA)	Registered with UK (MHRA)	Not registered with Canada (Health Canada)	Not registered with AU (TGA)	Registered with EU (EUDAMED)
VEA Align; spineEOS Eos Imaging Registered with US (FDA)	Eos Imaging	Registered with US (FDA)	Not registered with UK (MHRA)	Not registered with Canada (Health Canada)	Not registered with AU (TGA)	Not registered with EU (EUDAMED)
Velacur Sonic Incytes Registered with US (FDA)	Sonic Incytes	Registered with US (FDA)	Not registered with UK (MHRA)	Not registered with Canada (Health Canada)	Not registered with AU (TGA)	Not registered with EU (EUDAMED)
VELMENI for DENTISTS(V4D) Velmeni, Inc. Registered with US (FDA) UK (MHRA) AU (TGA) EU (EUDAMED)	Velmeni, Inc.	Registered with US (FDA)	Registered with UK (MHRA)	Not registered with Canada (Health Canada)	Registered with AU (TGA)	Registered with EU (EUDAMED)
Velmeni for Dentists (V4D) Endo-Perio Velmeni, Inc. Registered with US (FDA)	Velmeni, Inc.	Registered with US (FDA)	Not registered with UK (MHRA)	Not registered with Canada (Health Canada)	Not registered with AU (TGA)	Not registered with EU (EUDAMED)
VELYS™ Hip Navigation Depuy Ireland UC Registered with US (FDA)	Depuy Ireland UC	Registered with US (FDA)	Not registered with UK (MHRA)	Not registered with Canada (Health Canada)	Not registered with AU (TGA)	Not registered with EU (EUDAMED)
Vent Creativity Knee v1.0 (Hermes) Vent Creativity Registered with US (FDA)	Vent Creativity	Registered with US (FDA)	Not registered with UK (MHRA)	Not registered with Canada (Health Canada)	Not registered with AU (TGA)	Not registered with EU (EUDAMED)
Ventripoint Medical System Plus (VMS+) Ventripoint Diagnostics , Ltd. Registered with US (FDA) EU (EUDAMED)	Ventripoint Diagnostics , Ltd.	Registered with US (FDA)	Not registered with UK (MHRA)	Not registered with Canada (Health Canada)	Not registered with AU (TGA)	Registered with EU (EUDAMED)
Ventripoint Medical System Plus (VMS+) 3.0 Ventripoint Diagnostics , Ltd. Registered with US (FDA)	Ventripoint Diagnostics , Ltd.	Registered with US (FDA)	Not registered with UK (MHRA)	Not registered with Canada (Health Canada)	Not registered with AU (TGA)	Not registered with EU (EUDAMED)
Ventripoint Medical System Plus (VMS+) 4.0 Ventripoint Diagnostics , Ltd. Registered with US (FDA)	Ventripoint Diagnostics , Ltd.	Registered with US (FDA)	Not registered with UK (MHRA)	Not registered with Canada (Health Canada)	Not registered with AU (TGA)	Not registered with EU (EUDAMED)
Venue Ge Medical Systems, Inc. Registered with US (FDA)	Ge Medical Systems, Inc.	Registered with US (FDA)	Not registered with UK (MHRA)	Not registered with Canada (Health Canada)	Not registered with AU (TGA)	Not registered with EU (EUDAMED)
Venue GE Medical Systems Ultrasound and Primary Care Diagnostics, LLC Registered with US (FDA) UK (MHRA) Canada (Health Canada) EU (EUDAMED)	GE Medical Systems Ultrasound and Primary Care Diagnostics, LLC	Registered with US (FDA)	Registered with UK (MHRA)	Registered with Canada (Health Canada)	Not registered with AU (TGA)	Registered with EU (EUDAMED)
Venue Fit Ge Medical Systems, Inc. Registered with US (FDA)	Ge Medical Systems, Inc.	Registered with US (FDA)	Not registered with UK (MHRA)	Not registered with Canada (Health Canada)	Not registered with AU (TGA)	Not registered with EU (EUDAMED)
Venue Go GE Medical Systems Ultrasound and Primary Care Diagnostics, LLC Registered with US (FDA) UK (MHRA) Canada (Health Canada) EU (EUDAMED)	GE Medical Systems Ultrasound and Primary Care Diagnostics, LLC	Registered with US (FDA)	Registered with UK (MHRA)	Registered with Canada (Health Canada)	Not registered with AU (TGA)	Registered with EU (EUDAMED)
Venue; Venue Go; Venue Fit; Venue Sprint GE Medical Systems Ultrasound and Primary Care Diagnostics, LLC Registered with US (FDA)	GE Medical Systems Ultrasound and Primary Care Diagnostics, LLC	Registered with US (FDA)	Not registered with UK (MHRA)	Not registered with Canada (Health Canada)	Not registered with AU (TGA)	Not registered with EU (EUDAMED)
Vereos PET/CT Philips Medical Systems Nederland BV Registered with US (FDA) Canada (Health Canada) EU (EUDAMED)	Philips Medical Systems Nederland BV	Registered with US (FDA)	Not registered with UK (MHRA)	Registered with Canada (Health Canada)	Not registered with AU (TGA)	Registered with EU (EUDAMED)
Veritas Reverse Total Shoulder System Restor3d Registered with US (FDA)	Restor3d	Registered with US (FDA)	Not registered with UK (MHRA)	Not registered with Canada (Health Canada)	Not registered with AU (TGA)	Not registered with 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)	Spectrum Dynamics Medical, Ltd.	Registered with US (FDA)	Not registered with UK (MHRA)	Not registered with Canada (Health Canada)	Not registered with AU (TGA)	Not registered with EU (EUDAMED)
Versana Balance GE Medical Systems Ultrasound and Primary Care Diagnostics, LLC Registered with US (FDA)	GE Medical Systems Ultrasound and Primary Care Diagnostics, LLC	Registered with US (FDA)	Not registered with UK (MHRA)	Not registered with Canada (Health Canada)	Not registered with AU (TGA)	Not registered with EU (EUDAMED)
Versana Premier GE Medical Systems Ultrasound and Primary Care Diagnostics, LLC Registered with US (FDA)	GE Medical Systems Ultrasound and Primary Care Diagnostics, LLC	Registered with US (FDA)	Not registered with UK (MHRA)	Not registered with Canada (Health Canada)	Not registered with AU (TGA)	Not registered with EU (EUDAMED)
Versana Premier; Versana Premier Lotus; LOGIQ F GE Medical Systems Ultrasound and Primary Care Diagnostics, LLC Registered with US (FDA)	GE Medical Systems Ultrasound and Primary Care Diagnostics, LLC	Registered with US (FDA)	Not registered with UK (MHRA)	Not registered with Canada (Health Canada)	Not registered with AU (TGA)	Not registered with EU (EUDAMED)
VersaViewer Ge Medical Systems Scs Registered with US (FDA) UK (MHRA) EU (EUDAMED)	Ge Medical Systems Scs	Registered with US (FDA)	Registered with UK (MHRA)	Not registered with Canada (Health Canada)	Not registered with AU (TGA)	Registered with EU (EUDAMED)
Veuron-Brain-pAb3 Heuron Co., Ltd. Registered with US (FDA)	Heuron Co., Ltd.	Registered with US (FDA)	Not registered with UK (MHRA)	Not registered with Canada (Health Canada)	Not registered with AU (TGA)	Not registered with EU (EUDAMED)
VIDAvision VIDA DIAGNOSTICS, INC. Registered with US (FDA)	VIDA DIAGNOSTICS, INC.	Registered with US (FDA)	Not registered with UK (MHRA)	Not registered with Canada (Health Canada)	Not registered with AU (TGA)	Not registered with EU (EUDAMED)