510(k) K253818 ยท QAS Radiological Computer-Assisted Triage And Notification Software
Annalise Enterprise
| Applicant | Harrison-AI Medical Pty, Ltd., Sydney, AU |
| Decision | Substantially Equivalent, Mar 3, 2026 |
| Received | Nov 28, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K253818
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.