BriefCase-Triage: CARE Multi-Triage CT for Pneumothorax +3 more— 510(k) K253578

Name: FDA 510(k) clearance K253578
Creator: U.S. Food and Drug Administration
Published: 2026-02-26

Substantially Equivalent

Aidoc Medical , Ltd.

FDA 510(k) clearance K253578 for BriefCase-Triage: CARE Multi-Triage CT for Pneumothorax +3 more, Substantially Equivalent on 2026-02-26. Applicant: Aidoc Medical , Ltd.. Device class: 2.

Clearance details

Device name as filed: BriefCase-Triage: CARE Multi-Triage CT for Pneumothorax; Pericardial effusion; Large aortic aneurysm; Shoulder fracture or dislocation device
Applicant: Aidoc Medical , Ltd.
Product code: Code QAS
Device class: Class 2
Regulation: 21 CFR 892.2080
Advisory panel: Radiology
Date received: 2025-11-17
Decision date: 2026-02-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Tel Aviv, IL

Download summary PDF View on FDA.gov ↗

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K252421 — JLK-NCCT2026-03-24

More clearances from Aidoc Medical , Ltd.

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K251195 — BriefCase-Triage2026-01-27
K252970 — BriefCase-Triage: CARE Multi-triage CT Body2026-01-07
K253265 — BriefCase-Triage2025-11-06
K251406 — BriefCase-Triage2025-05-30
K250248 — BriefCase-Triage2025-02-14

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