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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
DASI Dimensions (V1.0)

Dasi Simulations

Registered with
  • US (FDA)
Data Analysis Facilitation Suite (DAFS)

Voronoi Health Analytics Incorporated

Registered with
  • US (FDA)
Deep Capsule® (Deep Capsule US)

Digestaid - Artificial Intelligence Development SA

Registered with
  • US (FDA)
DeepCatch

Medical IP Co., Ltd.

Registered with
  • US (FDA)
DeepContour (V1.0)

Wisdom Technologies., Inc.

Registered with
  • US (FDA)
DeepCT

Deep01 Limited

Registered with
  • US (FDA)
DEEPECHO

Deepecho

Registered with
  • US (FDA)
DeepFoqus (DeepFoqus-Accelerate)

Foqus Technologies, Inc.

Registered with
  • US (FDA)
Deep Learning Image Reconstruction

Ge Medical Systems, Inc.

Registered with
  • US (FDA)
Deep Learning Image Reconstruction

Ge Healthcare Japan Corporation

Registered with
  • US (FDA)
  • UK (MHRA)
  • Canada (Health Canada)
  • EU (EUDAMED)
Deep Learning Image Reconstruction for Gemstone Spectral Imaging

Ge Medical Systems, Inc.

Registered with
  • US (FDA)
Deep Recon

Shanghai United Imaging Healthcare Co., Ltd.

Registered with
  • US (FDA)
DeepRESP

Nox Medical Ehf

Registered with
  • US (FDA)
DeepRhythmAI

Medicalgorithmics SP Z.O.O.

Registered with
  • US (FDA)
  • UK (MHRA)
  • Canada (Health Canada)
  • EU (EUDAMED)
DeepTek CXR Analyzer v1.0

Deeptek Medical Imaging Private Limited

Registered with
  • US (FDA)
DEEPVESSEL FFR

Keyamed Na, Inc.

Registered with
  • US (FDA)
DeepXray

Alpha Intelligence Manifolds, Inc.

Registered with
  • US (FDA)
Definium Tempo Select

Ge Hualun Medical Systems Co. , Ltd.

Registered with
  • US (FDA)
  • UK (MHRA)
  • Canada (Health Canada)
  • EU (EUDAMED)
Delivery Date AI

Ultrasound AI

Registered with
  • US (FDA)
DELTAVIEW MODEL 2.1

Riverain Medical Group,Llc

Registered with
  • US (FDA)
DenSeeMammo

Statlife

Registered with
  • US (FDA)
densitas® densityAI™

Densitas, Inc.

Registered with
  • US (FDA)
  • Canada (Health Canada)
  • EU (EUDAMED)
DentalMonitoring

Dental Monitoring Sas

Registered with
  • US (FDA)
  • UK (MHRA)
  • Canada (Health Canada)
  • EU (EUDAMED)
Denti.AI Detect

Denti.Ai Technology, Inc.

Registered with
  • US (FDA)
DermaSensor

Dermasensor, Inc.

Registered with
  • US (FDA)
  • AU (TGA)
Diagnocat

Dgnct, LLC

Registered with
  • US (FDA)
  • AU (TGA)
DIFFMASTER OCTAVIA AUTOMATIC HEMATOLOGY ANALYZER

CellaVision AB

Registered with
  • US (FDA)
Digital Color Doppler Ultrasound System (P60 Series)

Sonoscape Medical Corp.

Registered with
  • US (FDA)
DIP/U.S. Urine Analysis Test System

Healthy.Io, Ltd.

Registered with
  • US (FDA)
Discovery MI Gen2

Ge Medical Systems, Inc.

Registered with
  • US (FDA)
  • EU (EUDAMED)
DM-Density

Densitas, Inc.

Registered with
  • US (FDA)
  • Canada (Health Canada)
d-Nav System

Hygieia, Inc.

Registered with
  • US (FDA)
Dose+ (1.0)

Mvision AI OY

Registered with
  • US (FDA)
DR 800 with MUSICA Dynamic

Agfa Healthcare Corp.

Registered with
  • US (FDA)
DrAid™ for Liver Segmentation

Vinbrain Joint Stock Company

Registered with
  • US (FDA)
DrAid for Radiology v1

Vinbrain Joint Stock Company

Registered with
  • US (FDA)
DreaMed Advisor Pro

DreaMed Diabetes, Ltd.

Registered with
  • US (FDA)
Dreem 3S

Beacon Biosignals, Inc.

Registered with
  • US (FDA)
DS Core Detect

Dentsply Sirona

Registered with
  • US (FDA)
DS Core Diagnosis

Dentsply Sirona

Registered with
  • US (FDA)
DTX Studio Assist

Nobel Biocare C/O Medicim NV

Registered with
  • US (FDA)
DTX Studio Clinic 3.0

Nobel Biocare AB

Registered with
  • US (FDA)
DTX Studio Clinic (4.0)

Nobel Biocare AB

Registered with
  • US (FDA)
DV. Target

Deepvoxel, Inc.

Registered with
  • US (FDA)
EarliPoint

Earlitec Diagnostics, Inc.

Registered with
  • US (FDA)
EarliPoint Assessment

Earlitec Diagnostics, Inc.

Registered with
  • US (FDA)
EarliPoint System

Earlitec Diagnostics, Inc.

Registered with
  • US (FDA)
EASYCELL CELL LOCATOR

Medica S.R.L.

Registered with
  • US (FDA)
eCARTv5 Clinical Deterioration Suite ("eCART")

Agilemd, Inc.

Registered with
  • US (FDA)
ECG-AI Low Ejection Fraction (LEF) 12-Lead algorithm (1010)

Anumana, Inc.

Registered with
  • US (FDA)