510(k) K012875 ยท LNH System, Nuclear Magnetic Resonance Imaging
SIGNA OPENSPEED MAGNETIC RESONANCE SYSTEM
| Applicant | GE Medical Systems, Waukesha WI, US |
| Decision | Substantially Equivalent, Nov 20, 2001 |
| Received | Aug 27, 2001 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K012875
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 23, 2021 | GE Healthcare, LLC GE Healthcare MR superconducting magnets, a component of GE Healthcare SIGNA OpenSpeed MR System, nuclear magnetic resonance imaging system. Open, Classified |
LNH | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.