510(k) K250831 ยท QFM Radiological Computer-Assisted Prioritization Software For Lesions
Annalise Enterprise
| Applicant | Annalise-Ai, Sydney, AU |
| Decision | Substantially Equivalent, Apr 23, 2025 |
| Received | Mar 19, 2025 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K250831
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.