510(k) K103327 ยท LNH System, Nuclear Magnetic Resonance Imaging
DISCOVERY MR750W 3.0T
| Applicant | Ge Healthcare Japan Corporation, Hino-Shi, Tokyo, JP |
| Decision | Substantially Equivalent, Sep 30, 2011 |
| Received | Nov 12, 2010 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K103327
| 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 |
| Jun 8, 2016 | GE Healthcare, LLC GE Healthcare, Discovery MR750w 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 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 |
| Apr 11, 2013 | GE Healthcare, LLC GE Healthcare, Discovery MR750w 3.0T System.
Part Number: 5352293.
Product Usage: It is indicated for use as a diagnostic imaging device to produce axial, sagittal, coronal, and oblique images, spe Terminated |
LNH | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.