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.
BriefCase
🇮🇱Aidoc Medical , Ltd.
Triage & notification (CADt)
qER
🇮🇳Qure.Ai Technologies
Triage & notification (CADt)
AI-Rad Companion Brain MR
🇺🇸Siemens Medical Solutions USA, Inc.
System, Image Processing, Radiological
MEDO ARIA
Medo.ai
MR image reconstruction/enhancement
Auto 3D Bladder Volume Tool
🇺🇸Butterfly Network, Inc.
System, Imaging, Pulsed Echo, Ultrasonic
QLAB Advanced Quantification Software
🇨🇳Philips Healthcare
MR image reconstruction/enhancement
uWS-MR
🇨🇳Shanghai United Imaging Healthcare Co., Ltd.
MR image reconstruction/enhancement
Syngo.CT CaScoring
🇺🇸Siemens Medical Solutions USA, Inc.
System, X-Ray, Tomography, Computed
HealthVCF
Zebra Medical Vision Ltd.
Lesion detection/diagnosis software
uMR 780
🇨🇳Shanghai United Imaging Healthcare Co., Ltd.
System, Nuclear Magnetic Resonance Imaging
AVIEW LCS
🇰🇷Coreline Soft Co.,Ltd
System, Image Processing, Radiological
EPIQ Diagnostic Ultrasound System Series, Affiniti Diagnostic Ultrasound System Series, CX50 Diagnostic Ultrasound System, Sparq Diagnostic Ultrasound System, Lumify Diagnostic Ultrasound System
Philips Ultrasound, Inc.
System, Imaging, Pulsed Doppler, Ultrasonic
NinesAI
Nines, Inc.
Triage & notification (CADt)
Caption Guidance
Caption Health
Image Acquisition And/Or Optimization Guided By Artificial Intelligence
CuraRad-ICH
CuraCloud Corp.
Triage & notification (CADt)
SIGNA Premier
GE Healthcare (GE Medical Systems, LLC)
System, Nuclear Magnetic Resonance Imaging
AIMI-Triage CXR PTX
RADLogics, Inc.
Lesion detection/diagnosis software
Rapid ICH
iSchemaView Incorporated
Triage & notification (CADt)
KOSMOS
🇺🇸EchoNous, Inc.
System, Imaging, Pulsed Doppler, Ultrasonic
Arterys MICA
🇺🇸Arterys, Inc.
MR image reconstruction/enhancement
MammoScreen
🇺🇸Therapixel
Breast CAD (tomosynthesis)
Hepatic VCAR
🇫🇷GE Medical Systems SCS
System, X-Ray, Tomography, Computed
Viz ICH
🇺🇸Viz.ai, Inc.
Triage & notification (CADt)
Al-Rad Companion (Musculoskeletal)
🇺🇸Siemens Medical Solutions USA, Inc.
System, X-Ray, Tomography, Computed
SonoVision Ultrasound Imaging System
Tissue Differentiation Intelligence, LLC
System, Imaging, Pulsed Doppler, Ultrasonic
syngo.CT Lung CAD
Siemens Medical Solutions, Inc
Lung Computed Tomography System, Computer-Aided Detection
Vantage Galan 3T, MRT-3020, V6.0 with AiCE Reconstruction Processing Unit for MR
🇯🇵Canon Medical Systems Corporation
System, Nuclear Magnetic Resonance Imaging
Transpara
ScreenPoint Medical B.V.
Breast CAD (tomosynthesis)
Broncholab
Fluidda Inc.
System, X-Ray, Tomography, Computed
icobrain-ctp
icometrix NV
System, Image Processing, Radiological
