510(k) K173592 ยท LNH System, Nuclear Magnetic Resonance Imaging
MAGNETOM Aera, MAGNETOM Skyra/Skyrafit, MAGNETOM Prisma/Prismafit, MAGNETOM Avantofit
| Applicant | Siemens Medical Solutions USA, Inc., Malvern PA, US |
| Decision | Substantially Equivalent, Feb 13, 2018 |
| Received | Nov 21, 2017 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K173592
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 30, 2025 | Siemens Medical Solutions USA, Inc MAGNETOM Prisma. Model Number: 10849582. Open, Classified |
LNH | None listed |
| Sep 30, 2025 | Siemens Medical Solutions USA, Inc MAGNETOM Skyra fit. Model Number: 10849580. Open, Classified |
LNH | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.