510(k) K083147 ยท LNH System, Nuclear Magnetic Resonance Imaging
DISCOVERY MR450
| Applicant | Ge Medical Systems, LLC, Waukesha WI, US |
| Decision | Substantially Equivalent, Nov 4, 2008 |
| Received | Oct 24, 2008 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K083147
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 2, 2017 | GE Medical Systems, LLC Optima MR450 1.5T
Product Usage:
1 .5T Brivo MR355 and 1.5T Optima MR360 are whole body magnetic resonance scanners designed to support high resolution, high signal-to-noise ratio, and short scan Terminated |
LNH | None listed |
| Aug 2, 2017 | GE Medical Systems, LLC Optima MR750 3.0T
Product Usage:
The Optima MR450 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 |
| May 1, 2014 | GE Healthcare, LLC GE Healthcare Discovery MR450, Discovery MR750, Optima MR450w, Optima MR450w equipped with the GEM option, Discovery MR750w, and Discovery MR750w equipped with the GEM option products.
Affected devic Terminated |
LNH | None listed |
| Apr 21, 2014 | GE Healthcare, LLC GE Healthcare, Discovery MR450, Discovery MR750, Optima MR450w, Optima MR 450w GEM, Discovery MR750w, and Discovery MR750w GEM products. Magnetic Resonance Diagnostic Device. 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 |
| May 1, 2013 | GE Healthcare, LLC GE Healthcare, Discovery MR750, Discovery 450, Optima 450W (with and without GEM), Signa HDx, Signa HDxt, Signa HDi, Signa Vibrant.
Indicated for use as a diagnostic imaging device. Terminated |
LNH | None listed |
| Mar 11, 2013 | GE Healthcare, LLC Optima MR450w, Discovery MR450, Discovery MR750, Signa HDx, Signa HDxt, Signa HDi, Signa Vibrant, and GE 1.5T Signa HDe MR System.
The GE Signa HDx MR system is a whole body magnetic resonance scann Terminated |
LNH | None listed |
| Sep 1, 2011 | GE Healthcare, LLC GE Healthcare, Discovery MR450
Product Usage: The Discovery MR450w is a whole body magnetic resonance scanner designed to support high resolution and high signal-to-noise ratio images in short exam Terminated |
LNH | None listed |
| Jan 11, 2010 | GE Medical Systems, LLC Signa Excite 1.5T, Signa HD 1.5T, Signa HDx 1.5T, Signa HDxT 1.5T, Signa HDe, GE DISCOVERY MR450 and the Signa 3.0T MR750 MRI systems when used in conjunction with Confirma's CADstream (These systems Terminated |
LNH | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.