510(k) K163234 ยท OUO Tomographic Imager Combining Emission Computed Tomography With Nuclear Magnetic Resonance
Biograph mMR with syngo MR E11P system software
| Applicant | Siemens Medical Solutions USA, Inc., Malvern PA, US |
| Decision | Substantially Equivalent, Feb 28, 2017 |
| Received | Nov 17, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K163234
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.