K253578
- 510(k) number
- K253578
- Device name
- BriefCase-Triage: CARE Multi-Triage CT for Pneumothorax; Pericardial effusion; Large aortic aneurysm; Shoulder fracture or dislocation device
- Applicant
- Aidoc Medical , Ltd. IL
- Product code
- QAS — Radiological Computer-Assisted Triage And Notificati
- Decision date
- 2026-02-26
- Date received
- 2025-11-17
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Radiology
PDFDownload 510(k) SummaryArchived here · 0.7 MB · U.S. public domain
Also available from FDA: K253578.pdf
Official FDA record: K253578
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.