510(k) K253794 ยท QIH Automated Radiological Image Processing Software
Prostate Core
| Applicant | Lucida Medical, Ltd., Cambridge, GB |
| Decision | Substantially Equivalent, Aug 10, 2026 |
| Received | Nov 28, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K253794
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.