BriefCase-Triage: CARE Multi-Triage CT for Pneumothorax +3 more— 510(k) K253578
Substantially EquivalentAidoc 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.
Summary
Aidoc Medical's device name is "BriefCase-Triage: CARE Multi-Triage CT for Pneumothorax; Pericardial effusion; Large aortic aneurysm; Shoulder fracture or dislocation device." It's filed under product code QAS, radiological computer-assisted triage and notification software. The record doesn't describe the software beyond that name and code name.
Class II, 21 CFR 892.2080. Radiology is both the classification panel and the review panel. It came in as a Traditional 510(k).
Aidoc Medical filed from Tel Aviv, Israel. FDA found it substantially equivalent 101 calendar days after receipt (November 17, 2025 to February 26, 2026).
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
- Product code QAS
- Device class
- Class 2
- Regulation
- 21 CFR 892.2080
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Tel Aviv, IL
Recent devices under product code QAS
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