510(k) K971684 ยท LNH System, Nuclear Magnetic Resonance Imaging
MAGNETOM PROJECT 047 SYSTEM (NUMARIS 3.5 SOFTWARE)
| Applicant | Siemens Medical Solutions USA, Inc., Iselin NJ, US |
| Decision | Substantially Equivalent, Aug 5, 1997 |
| Received | May 7, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K971684
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 25, 2008 | Siemens Medical Solutions USA, Inc Siemens Magnetom Sonata syngo, Model Number: 7106425, Siemens Medical Solutions USA, Malvern PA, 19355 Terminated |
LNH | None listed |
| Mar 25, 2008 | Siemens Medical Solutions USA, Inc Siemens Magnetom Sonata syngo, Model Number: 7104719, Siemens Medical Solutions USA, Malvern PA, 19355 Terminated |
LNH | None listed |
| Aug 24, 2004 | Siemens Medical Solutions USA, Inc Magnetom Symphony MRI System, Model 7106557 Terminated |
LNH | None listed |
| Aug 24, 2004 | Siemens Medical Solutions USA, Inc Magnetom Symphony MRI System, Model 7104594 Terminated |
LNH | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.