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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
RT Elements (4.5); (Elements) Multiple Brain Mets SRS; (Elements) Cranial SRS; (Elements) Spine SRS; (Elements) Cranial SRS w/ Cones; (Elements) RT Planning Platform; (Elements) Dose Review; (Elements) Retreatment Review; Elements Segmentation [Cranial , Basal Ganglia, Head & Neck, Pelvic, Spine, Thoracic & Spine, Extracranial] RT; Elements AI Tumor Segmentation RT; Elements SmartBrush [Angio, Spine] RT; Elements Object Management RT

Brainlab SE

Registered with
  • US (FDA)
RTHawk, HeartVista Cardiac Package

Heartvista, Inc.

Registered with
  • US (FDA)
RT-Mind-AI

Medmind Technology Co., Ltd.

Registered with
  • US (FDA)
RUS

Hutom, Inc.

Registered with
  • US (FDA)
RX-1 Rhythm Express Remote Cardiac Monitoring System

Vivaquant, Inc.

Registered with
  • US (FDA)
SafeBeat Rx App

Safebeat Rx, Inc.

Registered with
  • US (FDA)
SafeOp 3: Neural Informatix System

Alphatec Spine, Inc.

Registered with
  • US (FDA)
  • AU (TGA)
Saige-Density

DeepHealth, Inc.

Registered with
  • US (FDA)
Saige-Density (2.5.0)

DeepHealth, Inc.

Registered with
  • US (FDA)
Saige-Dx

DeepHealth, Inc.

Registered with
  • US (FDA)
Saige-Dx (3.1.0)

DeepHealth, Inc.

Registered with
  • US (FDA)
Saige-Q

DeepHealth, Inc.

Registered with
  • US (FDA)
Salix Central

Artrya Limited

Registered with
  • US (FDA)
Salix Coronary Plaque (V1.0.0)

Artrya Limited

Registered with
  • US (FDA)
Samsung ECG Monitor Application with Irregular Heart Rhythm Notification

Samsung Electronics Co., Ltd.

Registered with
  • US (FDA)
SANSA HSAT

Huxley Medical

Registered with
  • US (FDA)
Saranas Early Bird Bleed Monitoring System

Saranas, Inc.

Registered with
  • US (FDA)
Scaida BrainCT-ICH (v1.0)

Mlhealth 360

Registered with
  • US (FDA)
ScanDiags Ortho L-Spine MR-Q

Scandiags AG

Registered with
  • US (FDA)
ScanNav Anatomy: Peripheral Nerve Block

Intelligent Ultrasound Limited

Registered with
  • US (FDA)
  • EU (EUDAMED)
SCENARIA View Phase 5.0

FUJIFILM Corporation

Registered with
  • US (FDA)
ScreenDx

Imvaria, Inc.

Registered with
  • US (FDA)
SECOND LOOK (TM)

Icad, Inc.

Registered with
  • US (FDA)
Second Opinion

Pearl, Inc.

Registered with
  • US (FDA)
  • UK (MHRA)
  • AU (TGA)
  • EU (EUDAMED)
Second Opinion® 3D

Pearl, Inc.

Registered with
  • US (FDA)
Second Opinion® BLE

Pearl, Inc.

Registered with
  • US (FDA)
Second Opinion CC

Pearl, Inc.

Registered with
  • US (FDA)
Second Opinion® CS

Pearl, Inc.

Registered with
  • US (FDA)
Second Opinion® Panoramic

Pearl, Inc.

Registered with
  • US (FDA)
Second Opinion® Pediatric

Pearl, Inc.

Registered with
  • US (FDA)
Second Opinion Periapical Radiolucency Contours

Pearl, Inc.

Registered with
  • US (FDA)
See-Mode Augmented Reporting Tool, Thyroid (SMART-T)

See-Mode Technologies Pte, Ltd.

Registered with
  • US (FDA)
Segment 3DPrint

Medviso AB

Registered with
  • US (FDA)
  • EU (EUDAMED)
Segmentron Viewer

Dgnct, LLC

Registered with
  • US (FDA)
Seg Pro V3 (RT-300)

Ever Fortune.Ai, Co., Ltd.

Registered with
  • US (FDA)
Senographe Pristina 3D

Ge Healthcare

Registered with
  • US (FDA)
Sense System with IBT Electrodes

Infinite Biomedical Technologies

Registered with
  • US (FDA)
SENSICARDIAC

Diacoustic Medical (Pty)

Registered with
  • US (FDA)
SENSICARDIAC MOBI DIAGNOSTIC HEART MURMUR APPLICATION

Diacoustic Medical Devices (Pty) , Ltd.

Registered with
  • US (FDA)
Sepsis ImmunoScore

Prenosis, Inc.

Registered with
  • US (FDA)
Sight OLO

Sight Diagnostics , Ltd.

Registered with
  • US (FDA)
SIGNA 7.0T

Ge Medical Systems, Inc.

Registered with
  • US (FDA)
  • Canada (Health Canada)
  • EU (EUDAMED)
SIGNA Artist

Ge Healthcare (Tianjin) Company Limited

Registered with
  • US (FDA)
  • UK (MHRA)
  • Canada (Health Canada)
  • EU (EUDAMED)
SIGNA Artist Evo

Ge Healthcare (Tianjin) Company Limited

Registered with
  • US (FDA)
  • UK (MHRA)
  • Canada (Health Canada)
  • EU (EUDAMED)
SIGNA™ Bolt

Ge Medical Systems, Inc.

Registered with
  • US (FDA)
SIGNA Champion

Ge Healthcare (Tianjin) Company Limited

Registered with
  • US (FDA)
  • Canada (Health Canada)
  • EU (EUDAMED)
SIGNA Hero

Ge Healthcare (Ge Medical Systems, LLC)

Registered with
  • US (FDA)
SignalHF (IM008)

Implicity

Registered with
  • US (FDA)
SIGNA MAGNUS

Ge Medical Systems, Inc.

Registered with
  • US (FDA)
SIGNA Premier

Ge Medical Systems, Inc.

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