510(k) K091536 ยท LNH System, Nuclear Magnetic Resonance Imaging
OPTIMA MR450W
| Applicant | Ge Medical Systems, LLC, Waukesha WI, US |
| Decision | Substantially Equivalent, Jul 17, 2009 |
| Received | May 26, 2009 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K091536
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 8, 2020 | GE Healthcare, LLC System, Nuclear Magnetic Resonance Imaging - Product Usage: is a whole body magnetic resonance scanner designed to support high resolution, high signal-to-noise ratio, and short scan times. Terminated |
LNH | None listed |
| 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 |
| 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 |
| 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, 1.5T Optima MR450w
Product Usage: The Optima 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 |
| Feb 18, 2011 | GE Healthcare, LLC GE Healthcare, Optima MR450w 1.5T MR systems
The GE Signa MR750 System is a whole body magnetic resonance scanner designed to support high resolution, high signal-to-noise ratio, and short scan times. Terminated |
LNH | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.