510(k) K254180 ยท OWN Confocal Optical Imaging
PerfusiX-Imaging
| Applicant | LIMIS Development B.V., Leeuwarden, NL |
| Decision | Substantially Equivalent, Jul 24, 2026 |
| Received | Dec 23, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K254180
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.