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
Cartesion Prime (PCD-1000A/3) V10.15 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)
Cartesion Prime (PCD-1000A/3) V10.21 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)
Cartesion Prime (PCD-1000A/3) V10.8 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)
CARTO™ 3 EP Navigation System Software V8.0 (FG-5400-00, FG-5400-00U) Biosense Webster, Inc. Registered with US (FDA)	Biosense Webster, 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)
CARTO™ 3 EP Navigation System V8.4 Biosense Webster, Inc. Registered with US (FDA)	Biosense Webster, 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)
CDM Insights Oxford Brain Diagnostics, Ltd. Registered with US (FDA) UK (MHRA)	Oxford Brain Diagnostics, 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)
Ceevra Reveal 3 Ceevra, Inc. Registered with US (FDA)	Ceevra, 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)
Ceevra Reveal 3+ Ceevra, Inc. Registered with US (FDA)	Ceevra, 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)
CellaVision DC-1, CellaVision DC-1 PPA CellaVision AB Registered with US (FDA)	CellaVision AB	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)
CELLAVISION DM1200 WITH THE BODY FLUID APPLICTION CellaVision AB Registered with US (FDA)	CellaVision AB	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)
CELLAVISION DM96 AUTOMATIC HEMATOLOGY ANALYZER CellaVision AB Registered with US (FDA)	CellaVision AB	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)
CELLAVISION DM96 WITH THE BODY FLUID APPLICATION CellaVision AB Registered with US (FDA)	CellaVision AB	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)
Centricity Universal Viewer 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)
CEPHX3D Orca Dental AI , Ltd. Registered with US (FDA)	Orca Dental AI , 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)
CEPHX- Cephalometric Analysis Software Orca Dental AI , Ltd. Registered with US (FDA)	Orca Dental AI , 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)
CerebralGo Plus Yukun (Beijing) Technology Co., Ltd. Registered with US (FDA)	Yukun (Beijing) Technology 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)
CEREC Ortho Software Dentsply Sirona Registered with US (FDA)	Dentsply Sirona	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)
Ceribell Delirium Monitor System Ceribell, Inc. Registered with US (FDA)	Ceribell, 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)
Ceribell Status Epilepticus Monitor Ceribell, Inc. Registered with US (FDA)	Ceribell, 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)
Change Healthcare Anatomical AI Change Healthcare Canada Company Registered with US (FDA)	Change Healthcare Canada Company	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)
Chest-CAD Imagen Technologies, Inc. Registered with US (FDA)	Imagen 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)
ChestView US Gleamer Registered with US (FDA)	Gleamer	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)
CHLOE BLAST Fairtility Ltd Registered with US (FDA)	Fairtility 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)
CINA Avicenna.Ai Registered with US (FDA) Canada (Health Canada) AU (TGA) EU (EUDAMED)	Avicenna.Ai	Registered with US (FDA)	Not registered with UK (MHRA)	Registered with Canada (Health Canada)	Registered with AU (TGA)	Registered with EU (EUDAMED)
CINA-ASPECTS Avicenna.Ai Registered with US (FDA) Canada (Health Canada) EU (EUDAMED)	Avicenna.Ai	Registered with US (FDA)	Not registered with UK (MHRA)	Registered with Canada (Health Canada)	Not registered with AU (TGA)	Registered with EU (EUDAMED)
CINA-CHEST Avicenna.Ai Registered with US (FDA) Canada (Health Canada) EU (EUDAMED)	Avicenna.Ai	Registered with US (FDA)	Not registered with UK (MHRA)	Registered with Canada (Health Canada)	Not registered with AU (TGA)	Registered with EU (EUDAMED)
CINA-CSpine Avicenna.Ai Registered with US (FDA) EU (EUDAMED)	Avicenna.Ai	Registered with US (FDA)	Not registered with UK (MHRA)	Not registered with Canada (Health Canada)	Not registered with AU (TGA)	Registered with EU (EUDAMED)
CINA-iPE Avicenna.Ai Registered with US (FDA) Canada (Health Canada) EU (EUDAMED)	Avicenna.Ai	Registered with US (FDA)	Not registered with UK (MHRA)	Registered with Canada (Health Canada)	Not registered with AU (TGA)	Registered with EU (EUDAMED)
CINA-VCF Avicenna.Ai Registered with US (FDA)	Avicenna.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)
Cirrus Resting State fMRI Software Sora Neuroscience, Inc. Registered with US (FDA)	Sora Neuroscience, 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)
Claire™ OCT System Perimeter Medical Imaging Ai, Inc. Registered with US (FDA)	Perimeter Medical Imaging 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)
ClariCT.AI Claripi, Inc. Registered with US (FDA) UK (MHRA) AU (TGA) EU (EUDAMED)	Claripi, Inc.	Registered with US (FDA)	Registered with UK (MHRA)	Not registered with Canada (Health Canada)	Registered with AU (TGA)	Registered with EU (EUDAMED)
Clarify DL Ge Medical Systems Israel, Functional Imaging Registered with US (FDA)	Ge Medical Systems Israel, Functional 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)
ClariPulmo Claripi, Inc. Registered with US (FDA) UK (MHRA) AU (TGA) EU (EUDAMED)	Claripi, Inc.	Registered with US (FDA)	Registered with UK (MHRA)	Not registered with Canada (Health Canada)	Registered with AU (TGA)	Registered with EU (EUDAMED)
ClariSIGMAM Claripi, Inc. Registered with US (FDA) UK (MHRA) EU (EUDAMED)	Claripi, Inc.	Registered with US (FDA)	Registered with UK (MHRA)	Not registered with Canada (Health Canada)	Not registered with AU (TGA)	Registered with EU (EUDAMED)
Clarius AI Clarius Mobile Health Corp. Registered with US (FDA)	Clarius Mobile Health Corp.	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)
Clarius Bladder AI Clarius Mobile Health Corp. Registered with US (FDA) Canada (Health Canada)	Clarius Mobile Health Corp.	Registered with US (FDA)	Not registered with UK (MHRA)	Registered with Canada (Health Canada)	Not registered with AU (TGA)	Not registered with EU (EUDAMED)
Clarius Ejection Fraction AI Clarius Mobile Health Corp. Registered with US (FDA)	Clarius Mobile Health Corp.	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)
Clarius Median Nerve AI Clarius Mobile Health Corp. Registered with US (FDA) Canada (Health Canada)	Clarius Mobile Health Corp.	Registered with US (FDA)	Not registered with UK (MHRA)	Registered with Canada (Health Canada)	Not registered with AU (TGA)	Not registered with EU (EUDAMED)
Clarius OB AI Clarius Mobile Health Corp. Registered with US (FDA) Canada (Health Canada)	Clarius Mobile Health Corp.	Registered with US (FDA)	Not registered with UK (MHRA)	Registered with Canada (Health Canada)	Not registered with AU (TGA)	Not registered with EU (EUDAMED)
Clarius Prostate AI Clarius Mobile Health Corp. Registered with US (FDA) Canada (Health Canada)	Clarius Mobile Health Corp.	Registered with US (FDA)	Not registered with UK (MHRA)	Registered with Canada (Health Canada)	Not registered with AU (TGA)	Not registered with EU (EUDAMED)
Clarius Ultrasound Scanner Clarius Mobile Health Corp. Registered with US (FDA) UK (MHRA) Canada (Health Canada) AU (TGA)	Clarius Mobile Health Corp.	Registered with US (FDA)	Registered with UK (MHRA)	Registered with Canada (Health Canada)	Registered with AU (TGA)	Not registered with EU (EUDAMED)
Clarius Ultrasound System Clarius Mobile Health Corp. Registered with US (FDA) Canada (Health Canada)	Clarius Mobile Health Corp.	Registered with US (FDA)	Not registered with UK (MHRA)	Registered with Canada (Health Canada)	Not registered with AU (TGA)	Not registered with EU (EUDAMED)
CLARUS Carl Zeiss Meditec AG Registered with US (FDA) UK (MHRA)	Carl Zeiss Meditec AG	Registered with US (FDA)	Registered with UK (MHRA)	Not registered with Canada (Health Canada)	Not registered with AU (TGA)	Not registered with EU (EUDAMED)
CLARUS 700 Carl Zeiss Meditec AG Registered with US (FDA) Canada (Health Canada) EU (EUDAMED)	Carl Zeiss Meditec AG	Registered with US (FDA)	Not registered with UK (MHRA)	Registered with Canada (Health Canada)	Not registered with AU (TGA)	Registered with EU (EUDAMED)
ClearPoint Maestro Brain Model ClearPoint Neuro Inc Registered with US (FDA)	ClearPoint Neuro 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)
ClearPoint System (Software Version 2.2) ClearPoint Neuro Inc Registered with US (FDA)	ClearPoint Neuro 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)
ClearPoint System (Software Version 3.0) ClearPoint Neuro Inc Registered with US (FDA)	ClearPoint Neuro 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)
CLEARREAD +CONFIRM Riverain Technologies Registered with US (FDA) Canada (Health Canada)	Riverain Technologies	Registered with US (FDA)	Not registered with UK (MHRA)	Registered with Canada (Health Canada)	Not registered with AU (TGA)	Not registered with EU (EUDAMED)
ClearRead CT Riverain Technologies Registered with US (FDA) UK (MHRA) Canada (Health Canada) AU (TGA) EU (EUDAMED)	Riverain Technologies	Registered with US (FDA)	Registered with UK (MHRA)	Registered with Canada (Health Canada)	Registered with AU (TGA)	Registered with EU (EUDAMED)