510(k) K253023 ยท OUO Tomographic Imager Combining Emission Computed Tomography With Nuclear Magnetic Resonance
BIOGRAPH One
| Applicant | Siemens Healthineers AG, Forchheim, DE |
| Decision | Substantially Equivalent, Jan 15, 2026 |
| Received | Sep 19, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K253023
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.