510(k) K992746 ยท LNH System, Nuclear Magnetic Resonance Imaging
SIGNA HFO/I MAGNETIC RESONANCE SYSTEM
| Applicant | Ge Medical Systems, Inc., Milwaukee WI, US |
| Decision | Substantially Equivalent, Nov 9, 1999 |
| Received | Aug 16, 1999 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K992746
| 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 HFO/I MR System, nuclear magnetic resonance imaging system. Open, Classified |
LNH | None listed |
| Nov 15, 2018 | GE Healthcare, LLC Various GE Magnetic Resonance System on-site software version
Product Usage:
Magnetic resonance imaging equipment for general diagnostic use Terminated |
LNH | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.