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.
CoLumbo
Smart Soft Healthcare AD
MR image reconstruction/enhancement
Venue Go
🇺🇸GE Medical Systems Ultrasound and Primary Care Diagnostics
System, Imaging, Pulsed Doppler, Ultrasonic
ART-PLAN
🇫🇷TheraPanacea
RT auto-contouring
ElucidVivo A.3
Elucid Bioimaging Inc.
System, Image Processing, Radiological
Aquilion ONE (TSX-306A/3) V10.12 with Spectral Imaging System, Vitrea Software Package, VSTP-001A
🇯🇵Canon Medical Systems Corporation
System, X-Ray, Tomography, Computed
Swoop Portable MR Imaging System
🇺🇸Hyperfine, Inc.
System, Nuclear Magnetic Resonance Imaging
AIR Recon DL
GE Medical Systems,LLC (GE Healthcare)
System, Nuclear Magnetic Resonance Imaging
Voluson Expert 22, Voluson Expert 20, Voluson Expert 18
🇺🇸GE Medical Systems Ultrasound and Primary Care Diagnostics
System, Imaging, Pulsed Doppler, Ultrasonic
BriefCase
🇮🇱Aidoc Medical , Ltd.
Triage & notification (CADt)
Rayvolve
🇫🇷AZmed SAS
Radiological Computer Assisted Detection/Diagnosis Software For Fracture
Rapid LVO
🇺🇸iSchemaView, Inc.
Triage & notification (CADt)
SwiftMR
🇰🇷Airs Medical, Inc.
System, Image Processing, Radiological
BriefCase
🇮🇱Aidoc Medical , Ltd.
Triage & notification (CADt)
Rapid PE Triage and Notification (PETN)
🇺🇸iSchemaView, Inc.
Triage & notification (CADt)
syngo.CT CaScoring
🇺🇸Siemens Medical Solutions USA, Inc.
System, X-Ray, Tomography, Computed
Achieva, Ingenia, Ingenia CX, Ingenia Elition and Ingenia Ambition MR Systems
🇳🇱Philips Medical Systems Nederland B.V.
System, Nuclear Magnetic Resonance Imaging
Quantib Prostate
🇳🇱Quantib BV
System, Image Processing, Radiological
MAGNETOM Skyra Fit
🇺🇸Siemens Medical Solutions USA, Inc.
System, Nuclear Magnetic Resonance Imaging
Saige-Dx
DeepHealth, Inc.
Breast CAD (tomosynthesis)
Versana Balance
🇺🇸GE Medical Systems Ultrasound and Primary Care Diagnostics
System, Imaging, Pulsed Doppler, Ultrasonic
Overjet Caries Assist
Overjet, Inc.
Analyzer, Medical Image
Segment 3DPrint
🇸🇪Medviso AB
System, Image Processing, Radiological
MVision AI Segmentation
🇫🇮MVision AI
RT auto-contouring
MAGNETOM Lumina and MAGNETOM Vida Fit with syngo MR XA50A
🇺🇸Siemens Medical Solutions USA, Inc.
System, Nuclear Magnetic Resonance Imaging
aPROMISE X
🇸🇪EXINI Diagnostics AB
System, Image Processing, Radiological
EFAI RTSuite CT HN-Segmentation System
Ever Fortune.Ai, Co., Ltd.
RT auto-contouring
Philips Incisive CT
🇨🇳Philips Healthcare (Suzhou) Co., Ltd.
System, X-Ray, Tomography, Computed
BriefCase
🇮🇱Aidoc Medical , Ltd.
Triage & notification (CADt)
HealthOST
NanoxAI Ltd.
System, X-Ray, Tomography, Computed
Videa Caries Assist
🇺🇸VideaHealth Inc.
Analyzer, Medical Image
