510(k) K113490 ยท LNH System, Nuclear Magnetic Resonance Imaging
OPTIMA MR450W
| Applicant | Ge Medical Systems, LLC, Waukesha WI, US |
| Decision | Substantially Equivalent, Jan 13, 2012 |
| Received | Nov 23, 2011 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K113490
| 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 |
| Sep 27, 2013 | GE Healthcare, LLC GE Healthcare, Discovery MR750 3.0T, Optima MR450w 1.5T, and Discovery MR450 1.5T .
scanner designed to support high resolution, high signal-to-noise ratio, and short scan times. The GE Signa MR 750 Terminated |
LNH | None listed |
| Sep 23, 2013 | GE Healthcare, LLC GE 1.5T Signa HDxt, 3.0T Signa HDxt, Signa Vibrant, HD23 Software and the following model numbers: 2395001, 2395001-2, 2395001-3, 2395001-4, 5269997-2, 5269997-4, 2377062-61, 5127452-3, 5127452, 5337 Terminated |
LNH | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.