510(k) K191050 ยท LNH System, Nuclear Magnetic Resonance Imaging
MAGNETOM Aera and MAGNETOM Skyra with Software syngo MR E11E with Ischemic Heart Disease (IHD) Workflow
| Applicant | Siemens Medical Solutions USA, Inc., Malvern PA, US |
| Decision | Substantially Equivalent, Jul 12, 2019 |
| Received | Apr 19, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K191050
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.