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
TumorSight Viz SimBioSys, Inc. Registered with US (FDA)	SimBioSys, 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)
Tyto Insights for Crackles Detection Tyto Care , Ltd. Registered with US (FDA)	Tyto Care , 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)
Tyto Insights for Eardrum Bulging Detection Tyto Care , Ltd. Registered with US (FDA)	Tyto Care , 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)
Tyto Insights for Rhonchi Detection Tyto Care , Ltd. Registered with US (FDA)	Tyto Care , 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)
Tyto Insights for Wheeze Detection Tyto Care , Ltd. Registered with US (FDA)	Tyto Care , 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)
Tyto Insights for Wheeze Detection (with PCCP) Tyto Care , Ltd. Registered with US (FDA)	Tyto Care , 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)
Tyto Stethoscope Tyto Care , Ltd. Registered with US (FDA)	Tyto Care , 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)
Tyto Stethoscope (G3) Tyto Care , Ltd. Registered with US (FDA)	Tyto Care , 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)
uAI Easy Triage ICH 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)
uAI EasyTriage-Rib 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)
uAI Portal 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)
uAngio AVIVA 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)
uCT 550 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 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)
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 LS); 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)
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 Astra 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)
UNiD™ Spine Analyzer (SW3002) 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)