510(k) K251401 ยท KPS System, Tomography, Computed, Emission
PennPET Explorer Positron Emission Tomograph
| Applicant | Trustees of the University of Pennsylvania, Philadelphia PA, US |
| Decision | Substantially Equivalent, Nov 25, 2025 |
| Received | May 6, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K251401
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.