510(k) K253578 ยท QAS Radiological Computer-Assisted Triage And Notification Software
BriefCase-Triage: CARE Multi-Triage CT for Pneumothorax; Pericardial effusion; Large aortic aneurysm; Shoulder fracture or dislocation device
| Applicant | Aidoc Medical , Ltd., Tel Aviv, IL |
| Decision | Substantially Equivalent, Feb 26, 2026 |
| Received | Nov 17, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K253578
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.