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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.

1,255 devices · when each source was last refreshed

Registers: US (FDA) · UK (MHRA) · CA (Health Canada) · AU (TGA) · EU (EUDAMED)

Device
PowerLook Density Assessment V4.0

Icad, Inc.

Registered with
  • US (FDA)
PowerLook® Tomo Detection Software

Icad, Inc.

Registered with
  • US (FDA)
  • Canada (Health Canada)
PowerLook Tomo Detection V2 Software

Icad, Inc.

Registered with
  • US (FDA)
PRAEVAorta®2

Nurea

Registered with
  • US (FDA)
Precise Image

Philips Medical Systems Nederland BV

Registered with
  • US (FDA)
Precise Position

Philips Healthcare (Suzhou) Co., Ltd.

Registered with
  • US (FDA)
Precision AI Surgical Planning System (PAI-SPS)

Precision AI Pty, Ltd.

Registered with
  • US (FDA)
Precision DL

Ge Healthcare

Registered with
  • US (FDA)
PreemptiveAI Clinical SDK

Measure Labs, Inc. (Dba Preemptiveai, Inc.)

Registered with
  • US (FDA)
Prenuvo Body Composition

Prenuvo

Registered with
  • US (FDA)
  • Canada (Health Canada)
  • AU (TGA)
Preview Shoulder

Genesis Software Innovations

Registered with
  • US (FDA)
ProFound AI Software V2.1

Icad, Inc.

Registered with
  • US (FDA)
ProFound AI Software V3.0

Icad, Inc.

Registered with
  • US (FDA)
ProFound Detection (V4.0)

Icad, Inc.

Registered with
  • US (FDA)
prolaio eVO2peak Module (Version 1.0)

Prolaio, Inc.

Registered with
  • US (FDA)
Prostate MR AI (VA10A)

Siemens Healthcare GmbH

Registered with
  • US (FDA)
ProstatID

SCANMED, LLC

Registered with
  • US (FDA)
PROView

Ge Medical Systems Scs

Registered with
  • US (FDA)
  • UK (MHRA)
  • EU (EUDAMED)
PVAD IQ Software

Ultrasight, Inc.

Registered with
  • US (FDA)
qCT LN Quant

Qure.Ai Technologies

Registered with
  • US (FDA)
qER

Qure.Ai Technologies

Registered with
  • US (FDA)
qER-CTA (v1.0)

Qure.Ai Technologies

Registered with
  • US (FDA)
qER-Quant

Qure.Ai Technologies

Registered with
  • US (FDA)
QFR (3.0)

Qfr Solutions BV

Registered with
  • US (FDA)
QIR Suite

CASIS-CArdiac Simulation & Imaging Software

Registered with
  • US (FDA)
  • EU (EUDAMED)
QLAB Advanced Quantification Software

Philips Health Care

Registered with
  • US (FDA)
Qmenta Care Platform Family

Mint Labs, Inc., D/B/A. Qmenta

Registered with
  • US (FDA)
QOCA image Smart CXR Image Processing System

QUANTA COMPUTER INC.

Registered with
  • US (FDA)
QOCA® image Smart RT Contouring System

QUANTA COMPUTER INC.

Registered with
  • US (FDA)
QP-Brain®

Quibim S.L.

Registered with
  • US (FDA)
  • UK (MHRA)
  • EU (EUDAMED)
QP-Prostate® CAD

Quibim S.L.

Registered with
  • US (FDA)
QT Scanner 2000 Model A

Qt Imaging, Inc.

Registered with
  • US (FDA)
Quantib Brain

Quantib B.V.

Registered with
  • US (FDA)
  • UK (MHRA)
  • Canada (Health Canada)
  • AU (TGA)
Quantib Brain 1

Quantib B.V.

Registered with
  • US (FDA)
Quantib Brain 1.2

Quantib B.V.

Registered with
  • US (FDA)
Quantib ND

Quantib B.V.

Registered with
  • US (FDA)
  • UK (MHRA)
Quantib Prostate

Quantib B.V.

Registered with
  • US (FDA)
  • UK (MHRA)
  • EU (EUDAMED)
Quantitative Total Extensible Imaging (QTxI)

Aiq Solutions, Inc.

Registered with
  • US (FDA)
QUANTRA

Hologic Inc

Registered with
  • US (FDA)
  • UK (MHRA)
QuantX

Quantitative Insights, Inc.

Registered with
  • US (FDA)
QUIBIM Precision Prostate (qp-Prostate)

Quibim S.L.

Registered with
  • US (FDA)
QuickRad

Aikenist Technologies Pvt, Ltd.

Registered with
  • US (FDA)
QVCAD SYSTEM

Qview Medical, Inc.

Registered with
  • US (FDA)
qXR-BT

Qure.Ai Technologies

Registered with
  • US (FDA)
qXR-CTR

Qure.Ai Technologies

Registered with
  • US (FDA)
qXR-Detect

Qure.Ai Technologies

Registered with
  • US (FDA)
qXR-LN

Qure.Ai Technologies

Registered with
  • US (FDA)
qXR-PTX-PE

Qure.Ai Technologies

Registered with
  • US (FDA)
QyScore Software

Qynapse

Registered with
  • US (FDA)
Radiation Planning Assistant (RPA)

University of Texas, MD Anderson Cancer Center

Registered with
  • US (FDA)