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	Manufacturer	US	UK	CA	AU	EU
uCT 780 with uWS-CT-Dual Energy Analysis 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)
uCT ATLAS Astound with uWS-CT-Dual Energy Analysis 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)
uCT ATLAS Astound with uWS-CT-Dual Energy Analysis, uCT ATLAS with uWS-CT-Dual Energy Analysis 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)
uCT ATLAS with uWS-CT-Dual Energy Analysis 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)
uDR Aurora CX 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)
UltraExtend NX CUW-U001S V2.0 Ultrasound Image Analysis Program 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)
UltraSight AI Guidance Ultrasight, Inc. Registered with US (FDA) UK (MHRA)	Ultrasight, Inc.	Registered with US (FDA)	Registered with UK (MHRA)	Not registered with Canada (Health Canada)	Not registered with AU (TGA)	Not registered with EU (EUDAMED)
UltraSight Guidance Ultrasight, Inc. Registered with US (FDA) EU (EUDAMED)	Ultrasight, Inc.	Registered with US (FDA)	Not registered with UK (MHRA)	Not registered with Canada (Health Canada)	Not registered with AU (TGA)	Registered with EU (EUDAMED)
Ultrasound System 1300 Bk Medical Aps Registered with US (FDA)	Bk Medical Aps	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)
Ultrasound System 2300 Bk Medical Aps Registered with US (FDA)	Bk Medical Aps	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)
Ultrasound Workspace (UWS 6.0) Philips Ultrasound, Inc. Registered with US (FDA)	Philips Ultrasound, 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)
uMI Panorama 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)
uMI Panvivo 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)
uMI Panvivo (uMI Panvivo); uMI Panvivo (uMI Panvivo S) 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)
uMI Panvivo (uMI Panvivo); uMI Panvivo (uMI Panvivo S); uMI Panvivo (uMI Panvivo EX); uMI Panvivo (uMI Panvivo ES) 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)
uMR 680 Shanghai United Imaging Intelligence Co., Ltd. Registered with US (FDA)	Shanghai United Imaging Intelligence 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)
uMR 680 Shanghai United Imaging Healthcare Co., Ltd. Registered with US (FDA) AU (TGA)	Shanghai United Imaging Healthcare Co., Ltd.	Registered with US (FDA)	Not registered with UK (MHRA)	Not registered with Canada (Health Canada)	Registered with AU (TGA)	Not registered with EU (EUDAMED)
uMR 780 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)
uMR Jupiter 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)
uMR Omega 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)
uMR Omega with uWS-MR-MRS 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)
uMR Ultra 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)
UniCel® DxH 800 Coulter® Cellular Analysis System Beckman Coulter, Inc. Registered with US (FDA) Canada (Health Canada) EU (EUDAMED)	Beckman Coulter, Inc.	Registered with US (FDA)	Not registered with UK (MHRA)	Registered with Canada (Health Canada)	Not registered with AU (TGA)	Registered with EU (EUDAMED)
UNiD Spine Analyzer Medicrea International Registered with US (FDA) Canada (Health Canada)	Medicrea International	Registered with US (FDA)	Not registered with UK (MHRA)	Registered with Canada (Health Canada)	Not registered with AU (TGA)	Not registered with EU (EUDAMED)
UNiD™ Spine Analyzer Medicrea International S.A.S. (Medtronic) Registered with US (FDA)	Medicrea International S.A.S. (Medtronic)	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)
United Orthopedic Knee Patient Specific Instrumentation Enhatch, Inc. Registered with US (FDA)	Enhatch, 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)
uOmnispace Shanghai United Imaging Healthcare Co., Ltd. Registered with US (FDA) Canada (Health Canada) EU (EUDAMED)	Shanghai United Imaging Healthcare Co., Ltd.	Registered with US (FDA)	Not registered with UK (MHRA)	Registered with Canada (Health Canada)	Not registered with AU (TGA)	Registered with EU (EUDAMED)
uOmnispace.CT Shanghai United Imaging Healthcare Co., Ltd. Registered with US (FDA) Canada (Health Canada)	Shanghai United Imaging Healthcare 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)
uOmnispace.MI Shanghai United Imaging Healthcare Co., Ltd. Registered with US (FDA) Canada (Health Canada)	Shanghai United Imaging Healthcare 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)
uOmnispace.MR Shanghai United Imaging Healthcare Co., Ltd. Registered with US (FDA) Canada (Health Canada)	Shanghai United Imaging Healthcare 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)
uPMR 790 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)
Us2.ca 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)
Us2.v1 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)
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)
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)