510(k) K123068 ยท LNH System, Nuclear Magnetic Resonance Imaging
OPTIMA MR 430S
| Applicant | Ge Medical Systems, LLC, Wilmington MA, US |
| Decision | Substantially Equivalent, Nov 13, 2012 |
| Received | Oct 1, 2012 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K123068
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 23, 2021 | GE Healthcare, LLC GE Healthcare MR superconducting magnets, a component of GE Healthcare Optima MR430s System, nuclear magnetic resonance imaging system. Open, Classified |
LNH | None listed |
| Jun 8, 2016 | GE Healthcare, LLC Optima 1.5T MR430s MR Scanner, a diagnostic imaging device Terminated |
LNH | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.