510(k) K183221 ยท LNH System, Nuclear Magnetic Resonance Imaging
MAGNETOM Amira, MAGNETOM Sempra
| Applicant | Siemens Medical Solutions USA, Inc., Malvern PA, US |
| Decision | Substantially Equivalent, Feb 14, 2019 |
| Received | Nov 20, 2018 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K183221
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 29, 2023 | Siemens Medical Solutions USA, Inc (1) Over-ear headphones used with the MAGNETOM Amira MAGNETOM Free.Star MAGNETOM Sempra, MAGNETOM Free.Max, MAGNETOM Mica MAGNETOM Spectra
Siemens Model Number:11060845
Used with the following MAGN Open, Classified |
LNH | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.