510(k) K160618 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 Medical Systems, LLC, Waukesha WI, US |
| Decision | Substantially Equivalent, Jun 9, 2016 |
| Received | Mar 3, 2016 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K160618
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 13, 2025 | GE Medical Systems, LLC GE Signa Artist, Nuclear Magnetic Resonance Imaging System Open, Classified |
LNH | None listed |
| Aug 13, 2025 | GE Medical Systems, LLC GE Discovery MR450 1.5T, Nuclear Magnetic Resonance Imaging System Open, Classified |
LNH | None listed |
| Aug 13, 2025 | GE Medical Systems, LLC GE Optima MR450w 1.5T, Nuclear Magnetic Resonance Imaging System Open, Classified |
LNH | None listed |
| Aug 13, 2025 | GE Medical Systems, LLC GE SIGNA Architect, Nuclear Magnetic Resonance Imaging System Open, Classified |
LNH | None listed |
| Aug 13, 2025 | GE Medical Systems, LLC GE Discovery MR750 3.0T, Nuclear Magnetic Resonance Imaging System Open, Classified |
LNH | None listed |
| Jul 18, 2025 | GE Medical Systems, LLC SIGNA Architect Open, Classified |
LNH | None listed |
| Nov 22, 2024 | GE Medical Systems, LLC Discovery MR750w 3.0T, whole body magnetic resonance scanner Open, Classified |
LNH | None listed |
| Nov 22, 2024 | GE Medical Systems, LLC SIGNA Architect, Nuclear Magnetic Resonance Imaging System Open, Classified |
LNH | None listed |
| Nov 22, 2024 | GE Medical Systems, LLC SIGNA Architect AIR, Nuclear Magnetic Resonance Imaging System Open, Classified |
LNH | None listed |
| Aug 2, 2024 | GE Medical Systems, LLC SIGNA Architect, with affected software versions: DV26.0 to DV26.3, DV27.0 to DV27.3, DV28.0 to DV28.5, DV29.0, DV29.1, DV29.2, MR30.0, MR30.1; Nuclear Magnetic Resonance
Imaging System Open, Classified |
LNH | None listed |
| Aug 2, 2024 | GE Medical Systems, LLC Discovery MR750 3.0T, with affected software versions: DV24.0, DV25.0, DV25.1, DV26.0 to DV26.4, DV29.1, MR30.0, MR30.1; Nuclear Magnetic Resonance Imaging System Open, Classified |
LNH | None listed |
| Aug 2, 2024 | GE Medical Systems, LLC Discovery MR750w 3.0T, with affected software versions: DV24.0, DV25.0, DV25.1, DV26.0 to DV26.5, DV29.1, MR30.0, MR30.1; Nuclear Magnetic Resonance Imaging System Open, Classified |
LNH | None listed |
| Aug 2, 2024 | GE Medical Systems, LLC Discovery MR450 1.5T, with affected software versions: DV24.0, DV25.0, DV25.1, DV26.0; 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 |
| Aug 2, 2024 | GE Medical Systems, LLC SIGNA Artist, with affected software versions: DV26.0, DV27.1, DV28.1, 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 SIGNA Architect 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 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 SIGNA Artist 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 |
| Oct 16, 2021 | GE Healthcare, LLC SIGNA Architect nuclear magnetic resonance imaging system Terminated |
LNH | None listed |
| Oct 16, 2021 | GE Healthcare, LLC Discovery MR750w 3.0T nuclear magnetic resonance imaging system Terminated |
LNH | None listed |
| Oct 16, 2021 | GE Healthcare, LLC Discovery MR750 3.0T nuclear magnetic resonance imaging system Terminated |
LNH | None listed |
| Oct 16, 2021 | GE Healthcare, LLC SIGNA Artist nuclear magnetic resonance imaging system Terminated |
LNH | None listed |
| Oct 16, 2021 | GE Healthcare, LLC Optima MR450w 1.5T nuclear magnetic resonance imaging system Terminated |
LNH | None listed |
| Jul 12, 2021 | GE Healthcare, LLC SIGNA Architect - Product Usage: is a whole body magnetic resonance scanner designed to support high resolution, high signal-to-noise ratio, and short scan times. Open, Classified |
LNH | None listed |
| Jul 12, 2021 | GE Healthcare, LLC Discovery MR750w 3.0T - Product Usage: is a whole body magnetic resonance scanner designed to support high resolution, high signal-to-noise ratio, and short scan times. Open, Classified |
LNH | None listed |
| Jul 12, 2021 | GE Healthcare, LLC Discovery MR750 3.0T - Product Usage: is a whole body magnetic resonance scanner designed to support high resolution, high signal-to-noise ratio, and short scan times. Open, Classified |
LNH | None listed |
| Jul 12, 2021 | GE Healthcare, LLC SIGNA Artist, Nuclear Magnetic Resonance Imaging System Open, Classified |
LNH | None listed |
| Jul 12, 2021 | GE Healthcare, LLC Optima MR450w 1.5T, Nuclear Magnetic Resonance Imaging System Open, Classified |
LNH | None listed |
| Jul 12, 2021 | GE Healthcare, LLC Discovery MR450 1.5T, Nuclear Magnetic Resonance Imaging System Open, Classified |
LNH | None listed |
| 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 |
| 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 |
| Oct 3, 2018 | GE Medical Systems, LLC SIGNA Architect system
Product Usage:
The Signa Architect system is a whole body magnetic resonance scanner designed to support high resolution, high signal-to-noise ratio, and short scan times. It i Terminated |
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 |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.