510(k) K163312 ยท LNH System, Nuclear Magnetic Resonance Imaging
MAGNETOM Aera and MAGNETOM Skyra with syngo MR E11C - AP02 Software
| Applicant | Siemens Medical Solutions USA, Inc., Malvern PA, US |
| Decision | Substantially Equivalent, Jan 27, 2017 |
| Received | Nov 23, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K163312
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.