510(k) K132119 ยท LNH System, Nuclear Magnetic Resonance Imaging
MAGNETOM PRISMA, MAGNETOM PRISMA FIT
| Applicant | Siemens Medical Solutions USA, Inc., Mavern PA, US |
| Decision | Substantially Equivalent, Nov 22, 2013 |
| Received | Jul 9, 2013 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K132119
| 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 |
| Jul 9, 2019 | Siemens Medical Solutions USA, Inc MAGNETOM Prisma magnetic resonance diagnostic devices
Model #10849582 Terminated |
LNH | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.