510(k) K132376 ยท LNH System, Nuclear Magnetic Resonance Imaging
DISCOVERY MR750 3.0T, DISCOVERY MR450 1.5T, DISCOVERY MR750W 3.0T, OPTIMA MR450W 1.5T
| Applicant | Ge Healthcare (Ge Medical Systems, LLC), Waukesha WI, US |
| Decision | Substantially Equivalent, Nov 15, 2013 |
| Received | Jul 30, 2013 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K132376
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 13, 2025 | GE Medical Systems, LLC GE Optima MR450w 1.5T, Nuclear Magnetic Resonance Imaging System Open, Classified |
LNH | None listed |
| Aug 2, 2024 | GE Medical Systems, LLC Optima MR450w 1.5T, with affected software versions: DV24.0, DV25.0, DV25.1, DV26.0, DV29.1, MR30.0, MR30.1; Nuclear Magnetic Resonance Imaging System Open, Classified |
LNH | None listed |
| Dec 23, 2021 | GE Healthcare, LLC GE Healthcare MR superconducting magnets, a component of GE Healthcare Discovery MR750w 3.0T System, nuclear magnetic resonance imaging system. Open, Classified |
LNH | None listed |
| Dec 23, 2021 | GE Healthcare, LLC GE Healthcare MR superconducting magnets, a component of GE Healthcare Discovery MR750 3.0T System, nuclear magnetic resonance imaging system. Open, Classified |
LNH | None listed |
| Dec 23, 2021 | GE Healthcare, LLC GE Healthcare MR superconducting magnets, a component of GE Healthcare Optima MR450w 1.5T, Optima MR450w GEM system, nuclear magnetic resonance imaging system. Open, Classified |
LNH | None listed |
| Dec 23, 2021 | GE Healthcare, LLC GE Healthcare MR superconducting magnets, a component of GE Healthcare Discovery MR450 1.5T system, nuclear magnetic resonance imaging system. Open, Classified |
LNH | None listed |
| 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 |
| 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 |
| Aug 2, 2017 | GE Medical Systems, LLC Discovery MR750 3.0T
Product Usage:
Intended use: The Discovery MR750 3.0Tsystem is a whole body magnetic resonance scanner designed to support high resolution, high signal-to-noise ratio, and sho Terminated |
LNH | None listed |
| Feb 10, 2017 | GE Healthcare, LLC Discovery MR450
The systems are whole body magnetic resonance scanners designed to support high resolution, high signal-to-noise ratio, and short scan times. It is indicated for use as a diagnostic i Terminated |
LNH | None listed |
| Jun 8, 2016 | GE Healthcare, LLC GE Healthcare, Discovery MR750w Terminated |
LNH | None listed |
| Dec 28, 2015 | GE Medical Systems, LLC GE Healthcare, Discovery 3.0T MR750, 5148810-2, 5373011-2, 5499460-2. Terminated |
LNH | None listed |
| Nov 10, 2015 | GE Healthcare GE Healthcare, Discovery MR750w 3.0T.
Product Usage: The Discovery MR750 3.0T, Discovery MR450 1.5T, Discovery MR750w 3.0T and the Optima MR450w 1.5T Systems are whole body magnetic resonance scanne Terminated |
LNH | None listed |
| Nov 10, 2015 | GE Healthcare GE Healthcare, SIGNA HDxt 3.0T.
Product Usage:
The 1.5T Signa HDx family and 3.0T Signa HDx family are a whole body magnetic resonance scanner for use as a diagnostic imaging device. Terminated |
LNH | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.