510(k) K001773 ยท LNH System, Nuclear Magnetic Resonance Imaging
ORTHONE
| Applicant | Oni, Inc., North Andover MA, US |
| Decision | Substantially Equivalent, Aug 18, 2000 |
| Received | Jun 12, 2000 |
| Type | Abbreviated |
| FDA record | Open on fda.gov |
Recalls that name K001773
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 23, 2021 | GE Healthcare, LLC GE Healthcare MR superconducting magnets, a component of GE Healthcare Orthone (1.0T MSK Extreme) 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.