510(k) K123522 ยท LNH System, Nuclear Magnetic Resonance Imaging
OPTIMA MR450W
| Applicant | Ge Healthcare (Ge Medical Systems, LLC), Waukesha WI, US |
| Decision | Substantially Equivalent, Mar 13, 2013 |
| Received | Nov 15, 2012 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K123522
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 2, 2017 | GE Medical Systems, LLC Optima MR450w 1.5T
Product Usage:
The Optima MR450w 1.5T system is a whole body magnetic resonance scanner designed to support high resolution, high signal-to-noise ratio, and short scan times. It Terminated |
LNH | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.