510(k) K243605 ยท KPS System, Tomography, Computed, Emission
Aurora
| Applicant | Ge Medical Systems Israel, Functional Imaging, Tirat Hacarmel, IL |
| Decision | Substantially Equivalent, Jan 17, 2025 |
| Received | Nov 21, 2024 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K243605
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.