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
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)
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)
Ingenia, Ingenia CX, Ingenia Elition, Ingenia Ambition, MR 5300 and MR 7700 MR Systems 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)
Ingenia, Ingenia CX, Ingenia Elition S/X, Ingenia Ambition S/X, BlueSeal SE/XE/QE, MR 5300 and MR 7700 MR Systems including Upgrades 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)
inHEART MODELS Inheart, Sas Registered with US (FDA) AU (TGA)	Inheart, Sas	Registered with US (FDA)	Not registered with UK (MHRA)	Not registered with Canada (Health Canada)	Registered with AU (TGA)	Not registered with EU (EUDAMED)
INT Contour Carina Medical, LLC Registered with US (FDA)	Carina Medical, 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)
Intelligent NR Canon, Inc. Registered with US (FDA)	Canon, 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)
iNtuition-Structural Heart Module Terarecon,Inc. Registered with US (FDA)	Terarecon,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)
InVision Precision Cardiac Amyloid Invision Medical Technology Corporation Registered with US (FDA)	Invision Medical Technology 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)
InVision Precision LVEF (LVEF) Invision Medical Technology Corporation Registered with US (FDA)	Invision Medical Technology 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)
iQMR Medic Vision Imaging Solutions Registered with US (FDA)	Medic Vision Imaging 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)
iQ-solutions Sydney Neuroimaging Analysis Centre Pty, Ltd. Registered with US (FDA) AU (TGA)	Sydney Neuroimaging Analysis Centre Pty, 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)
IQ-UIP 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)
IRISeg Intuitive Surgical, Inc. Registered with US (FDA)	Intuitive Surgical, 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)
IRIS INTELLIGENT RETINAL IMAGING SYSTEM Intelligent Retinal Imaging Systems, LLC Registered with US (FDA)	Intelligent Retinal Imaging Systems, 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)
IRNF App Apple, Inc. Registered with US (FDA) UK (MHRA)	Apple, 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)
Irregular Rhythm Notification Feature (IRNF) Apple, Inc. Registered with US (FDA)	Apple, 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)
iSchemaView RAPID Ischemaview, Inc. Registered with US (FDA)	Ischemaview, 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)
JAZZ AI Medical AG Registered with US (FDA) EU (EUDAMED)	AI Medical AG	Registered with US (FDA)	Not registered with UK (MHRA)	Not registered with Canada (Health Canada)	Not registered with AU (TGA)	Registered with EU (EUDAMED)
JBS-LVO JLK, Inc. Registered with US (FDA)	JLK, 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)
Jewel Patch Wearable Cardioverter Defibrillator (P-WCD) (Jewel); Jewel P-WCD Firmware; Jewel Placement Accessory (Class Element Science, Inc. Registered with US (FDA)	Element Science, 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)
JLK-ICH JLK, Inc. Registered with US (FDA)	JLK, 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)
JLK-NCCT JLK, Inc. Registered with US (FDA)	JLK, 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)
JLK-SDH JLK, Inc. Registered with US (FDA)	JLK, 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)
KardiaAI AliveCor, Inc. Registered with US (FDA) Canada (Health Canada)	AliveCor, 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)
KidneyIntelX.dkd Renalytix Ai, Inc. Registered with US (FDA)	Renalytix 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)
KIDScore D3 Vitrolife AS Registered with US (FDA) UK (MHRA) EU (EUDAMED)	Vitrolife AS	Registered with US (FDA)	Registered with UK (MHRA)	Not registered with Canada (Health Canada)	Not registered with AU (TGA)	Registered with EU (EUDAMED)
Kneevoice Cartilage Evaluation System (750-3600-001) Kneevoice, Inc. Registered with US (FDA)	Kneevoice, 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)
KOALA IB Lab GmbH Registered with US (FDA)	IB Lab GmbH	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)
Koios DS Koios Medical, Inc. Registered with US (FDA) UK (MHRA) Canada (Health Canada)	Koios Medical, Inc.	Registered with US (FDA)	Registered with UK (MHRA)	Registered with Canada (Health Canada)	Not registered with AU (TGA)	Not registered with EU (EUDAMED)
Koios DS for Breast Koios Medical, Inc. Registered with US (FDA)	Koios 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)
Kosmos EchoNous, Inc Registered with US (FDA) AU (TGA) EU (EUDAMED)	EchoNous, Inc	Registered with US (FDA)	Not registered with UK (MHRA)	Not registered with Canada (Health Canada)	Registered with AU (TGA)	Registered with EU (EUDAMED)
LARALAB Laralab GmbH Registered with US (FDA)	Laralab GmbH	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)
LensHooke X12 PRO Semen Analysis System Bonraybio Co., Ltd. Registered with US (FDA) UK (MHRA)	Bonraybio Co., 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)
LensHooke X1 PRO Semen Quality Analyzer, LensHooke X1 PRO SE Semen Quality Analyzer Bonraybio Co., Ltd. Registered with US (FDA)	Bonraybio 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)
LensHooke X1 Pro Semen Quality Analyzer, LensHooke X1 Semen Quality Analyzer Bonraybio Co., Ltd. Registered with US (FDA)	Bonraybio 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)