510(k) K253844 ยท KPS System, Tomography, Computed, Emission
AnyScan 3.0 NM Scanner Family
| Applicant | Mediso Medical Imaging Systems, Ltd., Budapest, HU |
| Decision | Substantially Equivalent, Dec 30, 2025 |
| Received | Dec 2, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K253844
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.