510(k) K200213 ยท OUO Tomographic Imager Combining Emission Computed Tomography With Nuclear Magnetic Resonance
Biograph mMR with syngo MR E11P-AP01 system software
| Applicant | Siemens Medical Solutions USA, Inc., Malvern PA, US |
| Decision | Substantially Equivalent, May 11, 2020 |
| Received | Jan 28, 2020 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K200213
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 30, 2025 | Siemens Medical Solutions USA, Inc Biograph mMR. Model Number: 10433372. Open, Classified |
OUO | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.