510(k) K251153 ยท KPS System, Tomography, Computed, Emission
Aurora
| Applicant | Ge Medical Systems Israel, Tirat Hacarmel, IL |
| Decision | Substantially Equivalent, Jun 12, 2025 |
| Received | Apr 14, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K251153
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.