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
VUNO Med-DeepBrain VUNO INC Registered with US (FDA) UK (MHRA) EU (EUDAMED)	VUNO INC	Registered with US (FDA)	Registered with UK (MHRA)	Not registered with Canada (Health Canada)	Not registered with AU (TGA)	Registered with EU (EUDAMED)
VX1 Volta Medical Registered with US (FDA)	Volta Medical	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)
VX1+ Volta Medical Registered with US (FDA)	Volta Medical	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)
WatchMate Software Anumana, Inc. Registered with US (FDA)	Anumana, 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)
WAVE Clinical Platform Excel Medical Electronics, LLC Registered with US (FDA)	Excel Medical Electronics, 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)
WellDoc BlueStar Welldoc, Inc. Registered with US (FDA)	Welldoc, 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)
Withings ECG App Withings Registered with US (FDA)	Withings	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)
Withings Scan Monitor 2.0 Withings Registered with US (FDA)	Withings	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)
Workflow Box Mirada Medical, Ltd. Registered with US (FDA) UK (MHRA)	Mirada Medical, Ltd.	Registered with US (FDA)	Registered with UK (MHRA)	Not registered with Canada (Health Canada)	Not registered with AU (TGA)	Not registered with EU (EUDAMED)
WRDensity by Whiterabbit.ai Whiterabbit.Ai, Inc. Registered with US (FDA)	Whiterabbit.Ai, 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)
X100HT with Slide Loader with Full Field Peripheral Blood Smear (PBS) Application Scopio Labs , Ltd. Registered with US (FDA)	Scopio Labs , 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)
X100 With Full Field Peripheral Blood Smear (PBS) Application Scopio Labs , Ltd. Registered with US (FDA) EU (EUDAMED)	Scopio Labs , 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)
X100/X100HT with Full Field Peripheral Blood Smear (PBS) Application Scopio Labs , Ltd. Registered with US (FDA) UK (MHRA)	Scopio Labs , Ltd.	Registered with US (FDA)	Registered with UK (MHRA)	Not registered with Canada (Health Canada)	Not registered with AU (TGA)	Not registered with EU (EUDAMED)
X1-FFR Spectrawave, Inc. Registered with US (FDA)	Spectrawave, 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)
X9 Ultrasound System X9, Inc. Registered with US (FDA)	X9, 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)
Xeleris V Processing and Review System Ge Healthcare Registered with US (FDA)	Ge Healthcare	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)
Xeleris V Processing and Review Systems Ge Healthcare Registered with US (FDA)	Ge Healthcare	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)
X-Guide Surgical Navigation System X-Nav Technologies, LLC Registered with US (FDA) UK (MHRA) Canada (Health Canada) AU (TGA)	X-Nav Technologies, LLC	Registered with US (FDA)	Registered with UK (MHRA)	Registered with Canada (Health Canada)	Registered with AU (TGA)	Not registered with EU (EUDAMED)
XIDF-AWS801, Angio Workstation (Alphenix Workstation), V9.5 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)
xT CDx Tempus AI, Inc. Registered with US (FDA)	Tempus AI, 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)
xvision Spine System Augmedics, Ltd. Registered with US (FDA)	Augmedics, 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)
YSIO MAX Siemens Medical Solutions USA, Inc. Registered with US (FDA)	Siemens Medical Solutions USA, 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)
YSIO X.pree Siemens Medical Solutions Registered with US (FDA)	Siemens Medical Solutions	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)
ZEUS Platform (FG0501US) iRhythm Technologies, Inc. Registered with US (FDA)	iRhythm Technologies, 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)
ZEUS System iRhythm Technologies, Inc. Registered with US (FDA)	iRhythm Technologies, 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)
ZEUS System (Zio Watch) iRhythm Technologies, Inc. Registered with US (FDA)	iRhythm Technologies, 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)
Zio AT ECG Monitoring System, ZEUS System iRhythm Technologies, Inc. Registered with US (FDA)	iRhythm Technologies, 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)
Zio ECG Utilization Software (ZEUS) System iRhythm Technologies, Inc. Registered with US (FDA)	iRhythm Technologies, 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)
Ziostation2 Ziosoft, Inc. Registered with US (FDA) AU (TGA)	Ziosoft, Inc.	Registered with US (FDA)	Not registered with UK (MHRA)	Not registered with Canada (Health Canada)	Registered with AU (TGA)	Not registered with EU (EUDAMED)
Zio XT ECG Monitoring System, Zio AT ECG Monitoring System iRhythm Technologies, Inc. Registered with US (FDA)	iRhythm Technologies, 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)