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
HepaFat-AI Resonance Health Analysis Services Pty, Ltd. Registered with US (FDA)	Resonance Health Analysis Services Pty, 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)
HepaFatSmart (V2.0.0) Resonance Health Analysis Services Pty, Ltd. Registered with US (FDA)	Resonance Health Analysis Services Pty, 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)
Hepatica v1 (Hepatica v1.0.0) Perspectum Ltd Registered with US (FDA)	Perspectum 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)
Hepatic VCAR 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)
HERA W10 Diagnostic Ultrasound System, HERA W9 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)
HERA W9, HERA W10 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)
HERA Z20 Diagnostic Ultrasound System; HERA Z20e Diagnostic Ultrasound System; HERA Z20s Diagnostic Ultrasound System; R20 Diagnostic Ultrasound System; HERA Z30 Diagnostic Ultrasound System; R30 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)
HERA Z20, R20, HERA Z30, R30 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)
Heuron ICH 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)
Hi-D Imaging 4TAVR Hi-D Imaging AG Registered with US (FDA)	Hi-D Imaging AG	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)
HipCheck Stryker Corp. Registered with US (FDA)	Stryker 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)
HistoSonics® Planning Tool HistoSonics, Inc. Registered with US (FDA)	HistoSonics, 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)
HM70 EVO 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)
HS40 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)
Huxley SANSA Home Sleep Apnea Test (1000-00) Huxley Medical Registered with US (FDA)	Huxley 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)
HYDROS Robotic System (HY1000); HYDROS Handpiece (HH1000); HYDROS TRUS Probe (HU1000) Procept Biorobotics, Corporation Registered with US (FDA)	Procept Biorobotics, 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)
HYDROS Robotic System; HYDROS TRUS Probe; HYDROS Handpiece Procept Biorobotics, Corporation Registered with US (FDA)	Procept Biorobotics, 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)
HYPER AiR 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)
HYPER DLR 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)
Hyper Insight - ICH Sk, Inc. Registered with US (FDA)	Sk, 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)
HyperSnap Surgical System (HSS) Hypervision Surgical Ltd Registered with US (FDA)	Hypervision Surgical 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)
Hypertension Notification Feature (HTNF) Apple, Inc. Registered with US (FDA) AU (TGA)	Apple, 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)
i2Contour Mrimath, LLC Registered with US (FDA)	Mrimath, 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)
IB Lab LAMA IB Lab GmbH Registered with US (FDA) EU (EUDAMED)	IB Lab GmbH	Registered with US (FDA)	Not registered with UK (MHRA)	Not registered with Canada (Health Canada)	Not registered with AU (TGA)	Registered with EU (EUDAMED)
IB NEURO, VERSION 1.0 Imaging Biometrics, LLC Registered with US (FDA)	Imaging Biometrics, 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)
iCAC Device Bunkerhill, Inc. Registered with US (FDA)	Bunkerhill, 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)
iCAS-LV Highrad , Ltd. Registered with US (FDA)	Highrad , 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)
icobrain Icometrix Registered with US (FDA) Canada (Health Canada)	Icometrix	Registered with US (FDA)	Not registered with UK (MHRA)	Registered with Canada (Health Canada)	Not registered with AU (TGA)	Not registered with EU (EUDAMED)
icobrain aria Icometrix Registered with US (FDA)	Icometrix	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)
icobrain ctp Icometrix Registered with US (FDA) EU (EUDAMED)	Icometrix	Registered with US (FDA)	Not registered with UK (MHRA)	Not registered with Canada (Health Canada)	Not registered with AU (TGA)	Registered with EU (EUDAMED)
IDx-DR Idx, LLC Registered with US (FDA)	Idx, 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)
IDx-DR Digital Diagnostics, Inc. Registered with US (FDA)	Digital 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)
IDx-DR v2.3 Digital Diagnostics, Inc. Registered with US (FDA)	Digital 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)
Illumeo System PHILIPS MEDICAL SYSTEMS TECHNOLOGIES LTD. Registered with US (FDA)	PHILIPS MEDICAL SYSTEMS TECHNOLOGIES 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)
IM007 Implicity Registered with US (FDA)	Implicity	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)
IMAGE CHECKER Hologic Inc Registered with US (FDA) Canada (Health Canada)	Hologic Inc	Registered with US (FDA)	Not registered with UK (MHRA)	Registered with Canada (Health Canada)	Not registered with AU (TGA)	Not registered with EU (EUDAMED)
Imagine® Enterprise Suite Softlink International, Inc. Registered with US (FDA)	Softlink International, 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)
Imagio Breast Imaging System Seno Medical Instruments, Inc. Registered with US (FDA)	Seno Medical Instruments, 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)
Imbio PHA (4.0.0) Imbio, LLC Registered with US (FDA)	Imbio, 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)
Imbio RV/LV Software Imbio, LLC Registered with US (FDA)	Imbio, 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)
Impala AliveCor, Inc. Registered with US (FDA) AU (TGA)	AliveCor, 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)
InferCare RECIST Beijing Infervision Healthcare Medical Technology Co., Ltd. Registered with US (FDA)	Beijing Infervision Healthcare Medical 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)
InferOperate Suite Beijing Infervision Healthcare Medical Technology Co., Ltd. Registered with US (FDA)	Beijing Infervision Healthcare Medical 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)
InferRead CT Stroke.AI Infervision Medical Technology Co, Ltd Registered with US (FDA)	Infervision Medical 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)
InferRead Lung CT.AI Infervision Medical Technology Co, Ltd Registered with US (FDA)	Infervision Medical 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)
InferRead Lung CT.AI Beijing Infervision Technology Co., Ltd. Registered with US (FDA)	Beijing Infervision 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)
INFINITT DPS INFINITT Healthcare Co, Ltd Registered with US (FDA) UK (MHRA) EU (EUDAMED)	INFINITT Healthcare Co, Ltd	Registered with US (FDA)	Registered with UK (MHRA)	Not registered with Canada (Health Canada)	Not registered with AU (TGA)	Registered with EU (EUDAMED)
INFINITT PACS 7.0 INFINITT Healthcare Co, Ltd Registered with US (FDA) UK (MHRA) Canada (Health Canada) EU (EUDAMED)	INFINITT Healthcare Co, Ltd	Registered with US (FDA)	Registered with UK (MHRA)	Registered with Canada (Health Canada)	Not registered with AU (TGA)	Registered with EU (EUDAMED)
Informed Vital Core Application (IVC App) Mindset Medical, Inc. Registered with US (FDA)	Mindset Medical, 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)
Ingenia, Ingenia CX, Ingenia Elition, Ingenia Ambition, BlueSeal, MR 5300 and MR 7700 MR System Philips Medical Systems Nederland BV Registered with US (FDA)	Philips Medical Systems Nederland BV	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)