FDA-cleared — AI devices
Radiology AI devices on the FDA's AI-Enabled Device List (the Radiology panel). The list is not comprehensive and lags publication of decision summaries. Information only, never clinical advice.
LOGIQ E10
🇺🇸GE Medical Systems Ultrasound and Primary Care Diagnostics
System, Imaging, Pulsed Doppler, Ultrasonic
LOGIQ E10s, LOGIQ Fortis
GE Medical Systems Ultrasound and Primary Care Diagnostic,
System, Imaging, Pulsed Doppler, Ultrasonic
Lunit INSIGHT DBT
🇰🇷Lunit, Inc.
Breast CAD (tomosynthesis)
aprevo® Digital Segmentation
🇺🇸Carlsmed, Inc.
MR image reconstruction/enhancement
BriefCase-Triage
🇮🇱Aidoc Medical , Ltd.
Triage & notification (CADt)
Voluson Expert 22, Voluson Expert 20, Voluson Expert 18
🇺🇸GE Medical Systems Ultrasound and Primary Care Diagnostics
System, Imaging, Pulsed Doppler, Ultrasonic
ACUSON Sequoia Diagnostic Ultrasound System, ACUSON Sequoia Select Diagnostic Ultrasound System, ACUSON Origin Diagnostic Ultrasound System
🇺🇸Siemens Medical Solutions USA, Inc.
System, Imaging, Pulsed Doppler, Ultrasonic
MeVis Liver Suite
🇩🇪MeVis Medical Solutions AG
System, X-Ray, Tomography, Computed
SwiftMR
🇰🇷Airs Medical, Inc.
System, Image Processing, Radiological
Lumify Diagnostic Ultrasound System
🇺🇸Philips Ultrasound
System, Imaging, Pulsed Doppler, Ultrasonic
Rapid SDH
🇺🇸iSchemaView, Inc.
Triage & notification (CADt)
AI-Rad Companion Brain MR
Siemens Medical Solutions U.S.A.
MR image reconstruction/enhancement
MAGNETOM Vida; MAGNETOM Lumina; MAGNETOM Aera; MAGNETOM Skyra; MAGNETOM Prisma; MAGNETOM Prisma fit
🇺🇸Siemens Medical Solutions USA, Inc.
System, Nuclear Magnetic Resonance Imaging
Ultrasound System 1300
🇫🇷BK Medical Aps
System, Imaging, Pulsed Doppler, Ultrasonic
Sonix Health
🇰🇷Ontact Health Co., Ltd
MR image reconstruction/enhancement
Veuron-Brain-pAb3
🇰🇷Heuron Co., Ltd.
System, Image Processing, Radiological
SpotLight/SpotLight Duo (with DLIR option)
🇮🇱Arineta Ltd.
System, X-Ray, Tomography, Computed
NeuViz 128 Multi-Slice CT Scanner System
🇨🇳Neusoft Medical Systems Co., Ltd.
System, X-Ray, Tomography, Computed
Denti.AI Detect
🇨🇦Denti.AI Technology, Inc.
Analyzer, Medical Image
Swoop® Portable MR Imaging System®
🇺🇸Hyperfine, Inc.
System, Nuclear Magnetic Resonance Imaging
cmAngio® V1.0
🇺🇸CureMetrix, Inc.
MR image reconstruction/enhancement
Clarius Ultrasound Scanner
🇨🇦Clarius Mobile Health Corp.
System, Imaging, Pulsed Doppler, Ultrasonic
DeepTek CXR Analyzer v1.0
🇮🇳DeepTek Medical Imaging Pvt Ltd
Analyzer, Medical Image
Momentum Spine
🇨🇦Momentum Health Inc.
Device, Sensing, Optical Contour
EFAI NeuroSuite CT ICH Assessment System
Ever Fortune.Ai, Co., Ltd.
Triage & notification (CADt)
VUNO Med-DeepBrain
🇰🇷Vuno Inc.
MR image reconstruction/enhancement
uMI Panorama
🇨🇳Shanghai United Imaging Healthcare Co., Ltd.
System, Tomography, Computed, Emission
V8/H8 Diagnostic Ultrasound System, V7/H7 Diagnostic Ultrasound System, V6/H6 Diagnostic Ultrasound System
🇰🇷Samsung Medison Co., Ltd.
System, Imaging, Pulsed Doppler, Ultrasonic
Lung-CAD
🇺🇸Imagen Technologies, Inc
Analyzer, Medical Image
HipCheck
🇺🇸Stryker Corp.
MR image reconstruction/enhancement
