510(k) K022397 ยท LNH System, Nuclear Magnetic Resonance Imaging
SIGNA 3.0T MAGNETIC RESONANCE SYSTEM
| Applicant | GE Medical Systems, Milwaukee WI, US |
| Decision | Substantially Equivalent, Aug 22, 2002 |
| Received | Jul 23, 2002 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K022397
| 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 3.0T 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.