510(k) K250716 ยท LLZ System, Image Processing, Radiological
IMAGE ONE
| Applicant | Infomed Software, S.L., Barcelona, ES |
| Decision | Substantially Equivalent, Jul 23, 2025 |
| Received | Mar 10, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K250716
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.