FDA + EU cleared — AI devices
Radiology AI devices cleared by the FDA and CE-marked in the EU — the cross-jurisdiction set. Information only, never clinical advice.
BreastUS + EU
Lunit INSIGHT DBT
🇰🇷Lunit
Breast CAD (tomosynthesis)
Mammo / DBTDetection (CADe)510(k) 2023
Chest / ThoracicUS + EU
Annalise Enterprise CXR
🇦🇺Annalise.ai
Lesion detection/diagnosis software
X-ray / DRDetection (CADe)510(k) 2023
GeneralUS + EU
AIRS SwiftMR
🇰🇷AIRS Medical
MR image reconstruction/enhancement
MRReconstruction & enhancement510(k) 2022
EmergencyNeuro / Head & NeckChest / ThoracicUS + EU
Aidoc BriefCase-Triage
🇮🇱Aidoc
Triage & notification (CADt)
Multi-modalityTriage & notification (CADt)510(k) 2022
Neuro / Head & NeckUS + EU
icobrain
🇧🇪icometrix
Brain MR quantification
MRQuantification510(k) 2020
Neuro / Head & NeckEmergencyUS + EU
Viz LVO
🇺🇸Viz.ai
Triage & notification (CADt)
CTTriage & notification (CADt)De Novo 2018
CardiacUS + EU
HeartFlow FFRCT Analysis
🇺🇸HeartFlow
Coronary physiology from CT
CTQuantificationDe Novo 2014
