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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
MAGNETOM Terra; MAGNETOM Terra.X

Siemens Medical Solutions USA, Inc.

Registered with
  • US (FDA)
MAGNETOM Viato.Mobile

Siemens Medical Solutions USA, Inc.

Registered with
  • US (FDA)
MAGNETOM Vida; MAGNETOM Lumina; MAGNETOM Aera; MAGNETOM Skyra; MAGNETOM Prisma; MAGNETOM Prisma fit

Siemens Medical Solutions USA, Inc.

Registered with
  • US (FDA)
MAGNETOM Vida, MAGNETOM Sola, MAGNETOM Lumina, MAGNETOM Altea

Siemens Medical Solutions USA, Inc.

Registered with
  • US (FDA)
MAGNETOM Vida with syngo MR XA50A

Siemens Medical Solutions USA, Inc.

Registered with
  • US (FDA)
Magnifico Open (100009900)

Esaote, S.P.A.

Registered with
  • US (FDA)
MALDI BIOTYPER CA (MBT-CA) SYSTEM

Bruker Daltonics GmbH & Co KG

Registered with
  • US (FDA)
MAMMOMAT INSPIRATION TOMOSYNTHESIS OPTION

Siemens Medical Solutions USA, Inc.

Registered with
  • US (FDA)
MammoScreen

Therapixel

Registered with
  • US (FDA)
  • Canada (Health Canada)
  • EU (EUDAMED)
MammoScreen 2.0

Therapixel

Registered with
  • US (FDA)
MammoScreen® (3)

Therapixel

Registered with
  • US (FDA)
MammoScreen® (4)

Therapixel

Registered with
  • US (FDA)
MammoScreen® (5)

Therapixel

Registered with
  • US (FDA)
MammoScreen BD

Therapixel

Registered with
  • US (FDA)
MammoSightAI

Neurocareai, Inc. (Dba Savelife.Ai)

Registered with
  • US (FDA)
MARGINPROBE SYSTEM

Dilon Medical Technologies, Ltd.

Registered with
  • US (FDA)
Masimo SafetyNet

Masimo Corp.

Registered with
  • US (FDA)
  • AU (TGA)
MATRx plus

ZEPHYR SLEEP TECHNOLOGIES

Registered with
  • US (FDA)
MaxFOV 2

Ge Medical Systems, Inc.

Registered with
  • US (FDA)
Mazor X System (Mazor X Stealth Edition)

Mazor Robotics , Ltd.

Registered with
  • US (FDA)
  • AU (TGA)
ME-APDS / MAGENTIQ-COLO

Magentiq Eye, Ltd.

Registered with
  • US (FDA)
  • EU (EUDAMED)
MediAI-BA

Crescom Co., Ltd.

Registered with
  • US (FDA)
MediAI-OA

Crescom Co., Ltd.

Registered with
  • US (FDA)
Median LCS (internal name) / eyonis LCS (trade name) (1.0)

Median Technologies

Registered with
  • US (FDA)
Medical Image Post-processing Software (uOmnispace.CT)

Shanghai United Imaging Healthcare Co., Ltd.

Registered with
  • US (FDA)
Medihub Prostate

JLK, Inc.

Registered with
  • US (FDA)
MEDIP PRO

Medical IP Co., Ltd.

Registered with
  • US (FDA)
MEDO ARIA

Medo.Ai

Registered with
  • US (FDA)
MEDO-Thyroid

Medo DX Pte. , Ltd.

Registered with
  • US (FDA)
MELAFIND

Strata Skin Sciences, Inc.

Registered with
  • US (FDA)
Merge PACS

Merge Healthcare Incorporated

Registered with
  • US (FDA)
  • UK (MHRA)
  • Canada (Health Canada)
MeRT System

Wave Neuroscience

Registered with
  • US (FDA)
Methinks CTA Stroke

Methinks Software SL

Registered with
  • US (FDA)
Methinks NCCT Stroke

Methinks Software SL

Registered with
  • US (FDA)
MeVis Liver Suite

Mevis Medical Solutions AG

Registered with
  • US (FDA)
  • UK (MHRA)
  • EU (EUDAMED)
Micro C Medical Imaging System, M01

OXOS MEDICAL, INC.

Registered with
  • US (FDA)
MICSI-RMT

Microstructure Imaging, Inc.

Registered with
  • US (FDA)
MIMOSA Imager

Mimosa Diagnostics, Inc.

Registered with
  • US (FDA)
Minuteful - kidney test

Healthy.Io, Ltd.

Registered with
  • US (FDA)
  • EU (EUDAMED)
MI View&GO

Siemens Medical Solutions USA, Inc.

Registered with
  • US (FDA)
  • UK (MHRA)
  • Canada (Health Canada)
  • EU (EUDAMED)
Momentum Spine

Momentum Health, Inc.

Registered with
  • US (FDA)
Monaco RTP System (6.3)

Elekta Solutions AB

Registered with
  • US (FDA)
Morph

BeauBrain Healthcare, Inc.

Registered with
  • US (FDA)
MOZI TPS

Manteia Technologies Co., Ltd.

Registered with
  • US (FDA)
  • AU (TGA)
  • EU (EUDAMED)
MPXA-2000

Medipixel, Inc.

Registered with
  • US (FDA)
MR 5300 and MR 7700 R11 MR Systems

Philips Medical Systems Nederlands B.V.

Registered with
  • US (FDA)
MRCAT brain

Philips Medical Systems MR Finland

Registered with
  • US (FDA)
MRCAT Head & Neck

PHILIPS OY

Registered with
  • US (FDA)
MR Contour DL

Ge Healthcare

Registered with
  • US (FDA)
  • EU (EUDAMED)
MRCP+ v1.0

Perspectum Diagnostics, Ltd.

Registered with
  • US (FDA)