510(k) K121160 ยท LNH System, Nuclear Magnetic Resonance Imaging
MAGNETOM SPECTRA
| Applicant | Siemens Medical Solutions USA, Inc., Mavern PA, US |
| Decision | Substantially Equivalent, Jul 16, 2012 |
| Received | Apr 16, 2012 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K121160
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 30, 2025 | Siemens Medical Solutions USA, Inc MAGNETOM Spectra as the following:
1. MAGNETOM Spectra. Model Number: 10837643.
2. MAGNETOM Spectra (CN). Model Number: 10655588. Open, Classified |
LNH | None listed |
| Jul 9, 2019 | Siemens Medical Solutions USA, Inc MAGNETOM Spectra magnetic resonance diagnostic devices
Model # 10837643 Terminated |
LNH | None listed |
| Sep 26, 2012 | Siemens Medical Solutions USA, Inc Siemens Magnetom Skyra, Verio, Spectra and Biograph MMR
Nuclear Magnetic Resonance Imaging System and Tomographic Imager Terminated |
LNH | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.