BriefCase-Triage: CARE Multi-Triage CT for Pneumothorax; Pericardial effusion; Large aortic aneurysm; Shoulder fracture or dislocation device

Aidoc Medical , Ltd. · K253578 · 2026-02-26

BriefCase-Triage: CARE Multi-Triage CT for Pneumothorax; Pericardial effusion; Large aortic aneurysm; Shoulder fracture or dislocation device is an AI-enabled medical device from Aidoc Medical , Ltd., listed by FDA (510(k), K253578) with a decision date of 2026-02-26. Review panel: Radiology.

FDA submission numberK253578
Pathway510(k)
CompanyAidoc Medical , Ltd.
Review panel (specialty)Radiology
FDA decision date2026-02-26
DecisionSubstantially Equivalent
Product codeQAS
ClassificationRadiological Computer-Assisted Triage And Notification Software
Device class2
Regulation number892.2080
Review time (calendar days)101
Applicant countryIL

Official FDA database record · FDA AI-enabled device list

More devices from Aidoc Medical , Ltd. · All Radiology AI devices · Full device index

Data from FDA's AI-enabled device list and openFDA. Informational only; verify against the FDA record.