# K160618: Discovery MR750 3.0T, Discovery MR450 1.5T, Discovery MR750w 3.0T, Optima MR450w 1.5T

- Pathway: 510(k) (Special)
- Applicant: Ge Medical Systems, LLC
- Decided: Jun 9, 2016 after 98 days
- Product code: LNH (System, Nuclear Magnetic Resonance Imaging)
- Device class: 2
- Regulation: 21 CFR 892.1000
- Recalls of this device: 40 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 13 generations back to K971684 (1997). 30 ancestors in all.
16 later devices descend from it; 1 cites it directly.
5 of 47 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K142085: Discovery MR750 3.0T ,Discovery MR450 1.5T, Discovery MR750 3.0T,Optima MR450W 1.5T, Ge Medical Systems, LLC (2014) Summary page 4.

## Most influential descendants
- K163331: Discovery MR750 3.0T; Discovery MR750w 3.0T;Discovery MR450 1.5T; Discovery MR450w 1.5T; SIGNA Architect and SIGNA Artist (2017), 15 descendants of its own
- K171128: SIGNA Premier (2017), 11 descendants of its own
- K183231: SIGNA Premier (2019), 10 descendants of its own
- K193282: SIGNA Premier (2020), 9 descendants of its own
- K213717: AIR Recon DL (2022), 2 descendants of its own

## Recalls of this device
- Jun 20, 2025 · Class II · Z-2306-2025: GE HealthCare has become aware that for certain MR systems (SIGNA Artist, SIGNA Voyager, Discovery MR450 1.5T, Optima MR450w 1.5T, SIGNA Architect, SIGNA Premier, SIGNA UHP, Discovery MR750 3.0T, Disc
- Jun 20, 2025 · Class II · Z-2299-2025: GE HealthCare has become aware that for certain MR systems (SIGNA Artist, SIGNA Voyager, Discovery MR450 1.5T, Optima MR450w 1.5T, SIGNA Architect, SIGNA Premier, SIGNA UHP, Discovery MR750 3.0T, Disc
- Jun 20, 2025 · Class II · Z-2302-2025: GE HealthCare has become aware that for certain MR systems (SIGNA Artist, SIGNA Voyager, Discovery MR450 1.5T, Optima MR450w 1.5T, SIGNA Architect, SIGNA Premier, SIGNA UHP, Discovery MR750 3.0T, Disc
- Jun 20, 2025 · Class II · Z-2303-2025: GE HealthCare has become aware that for certain MR systems (SIGNA Artist, SIGNA Voyager, Discovery MR450 1.5T, Optima MR450w 1.5T, SIGNA Architect, SIGNA Premier, SIGNA UHP, Discovery MR750 3.0T, Disc
- Jun 20, 2025 · Class II · Z-2301-2025: GE HealthCare has become aware that for certain MR systems (SIGNA Artist, SIGNA Voyager, Discovery MR450 1.5T, Optima MR450w 1.5T, SIGNA Architect, SIGNA Premier, SIGNA UHP, Discovery MR750 3.0T, Disc
- May 23, 2025 · Class II · Z-2130-2025: GE HealthCare has become aware that gradient coils for certain MR systems (see affected product list in this letter), under specific conditions, can produce elevated acoustic noise during scanning. As
- Oct 28, 2024 · Class II · Z-0517-2025: Gradient coils for certain MR systems (see affected product list in this letter), under specific conditions, can produce elevated acoustic noise during scanning.
- Oct 28, 2024 · Class II · Z-0518-2025: Gradient coils for certain MR systems (see affected product list in this letter), under specific conditions, can produce elevated acoustic noise during scanning.
- Oct 28, 2024 · Class II · Z-0519-2025: Gradient coils for certain MR systems (see affected product list in this letter), under specific conditions, can produce elevated acoustic noise during scanning.
- Jun 14, 2024 · Class II · Z-2464-2024: GE HealthCare has become aware that for certain MR systems, the system predicted B1+RMS value can exceed the B1+RMS user prescribed limit when scanning in Low SAR Mode and the following two conditions
- Jun 14, 2024 · Class II · Z-2467-2024: GE HealthCare has become aware that for certain MR systems, the system predicted B1+RMS value can exceed the B1+RMS user prescribed limit when scanning in Low SAR Mode and the following two conditions
- Jun 14, 2024 · Class II · Z-2465-2024: GE HealthCare has become aware that for certain MR systems, the system predicted B1+RMS value can exceed the B1+RMS user prescribed limit when scanning in Low SAR Mode and the following two conditions
- Jun 14, 2024 · Class II · Z-2468-2024: GE HealthCare has become aware that for certain MR systems, the system predicted B1+RMS value can exceed the B1+RMS user prescribed limit when scanning in Low SAR Mode and the following two conditions
- Jun 14, 2024 · Class II · Z-2469-2024: GE HealthCare has become aware that for certain MR systems, the system predicted B1+RMS value can exceed the B1+RMS user prescribed limit when scanning in Low SAR Mode and the following two conditions
- Jun 14, 2024 · Class II · Z-2459-2024: GE HealthCare has become aware that for certain MR systems, the system predicted B1+RMS value can exceed the B1+RMS user prescribed limit when scanning in Low SAR Mode and the following two conditions
- Dec 23, 2021 · Class II · Z-0600-2022: The magnetic resonance systems could potentially have a cryogen ventilation system that does not meet the venting requirements.
- Dec 23, 2021 · Class II · Z-0601-2022: The magnetic resonance systems could potentially have a cryogen ventilation system that does not meet the venting requirements.
- Dec 23, 2021 · Class II · Z-0591-2022: The magnetic resonance systems could potentially have a cryogen ventilation system that does not meet the venting requirements.
- Dec 23, 2021 · Class II · Z-0593-2022: The magnetic resonance systems could potentially have a cryogen ventilation system that does not meet the venting requirements.
- Dec 23, 2021 · Class II · Z-0594-2022: The magnetic resonance systems could potentially have a cryogen ventilation system that does not meet the venting requirements.
- Dec 23, 2021 · Class II · Z-0602-2022: The magnetic resonance systems could potentially have a cryogen ventilation system that does not meet the venting requirements.
- Aug 26, 2021 · Class II · Z-0135-2022: Under certain conditions, some slices may be missing which can lead to a gap of anatomy in the 3D Volume images.
- Aug 26, 2021 · Class II · Z-0136-2022: Under certain conditions, some slices may be missing which can lead to a gap of anatomy in the 3D Volume images.
- Aug 26, 2021 · Class II · Z-0133-2022: Under certain conditions, some slices may be missing which can lead to a gap of anatomy in the 3D Volume images.
- Aug 26, 2021 · Class II · Z-0139-2022: Under certain conditions, some slices may be missing which can lead to a gap of anatomy in the 3D Volume images.
- Aug 26, 2021 · Class II · Z-0140-2022: Under certain conditions, some slices may be missing which can lead to a gap of anatomy in the 3D Volume images.
- Jun 4, 2021 · Class II · Z-2061-2021: GE Healthcare has recently become aware of an issue on the affected products listed below where the "Patient Orientation" button may inadvertently be clicked when intending to click on the "Save RX" b
- Jun 4, 2021 · Class II · Z-2056-2021: GE Healthcare has recently become aware of an issue on the affected products listed below where the "Patient Orientation" button may inadvertently be clicked when intending to click on the "Save RX" b
- Jun 4, 2021 · Class II · Z-2053-2021: GE Healthcare has recently become aware of an issue on the affected products listed below where the "Patient Orientation" button may inadvertently be clicked when intending to click on the "Save RX" b
- Jun 4, 2021 · Class II · Z-2055-2021: GE Healthcare has recently become aware of an issue on the affected products listed below where the "Patient Orientation" button may inadvertently be clicked when intending to click on the "Save RX" b
- Jun 4, 2021 · Class II · Z-2063-2021: GE Healthcare has recently become aware of an issue on the affected products listed below where the "Patient Orientation" button may inadvertently be clicked when intending to click on the "Save RX" b
- Jun 4, 2021 · Class II · Z-2064-2021: GE Healthcare has recently become aware of an issue on the affected products listed below where the "Patient Orientation" button may inadvertently be clicked when intending to click on the "Save RX" b
- Sep 8, 2020 · Class II · Z-0129-2021: Potential electrical arc flash within the Power Gradient & RF (PGR) Cabinet.
- Sep 8, 2020 · Class II · Z-0130-2021: Potential electrical arc flash within the Power Gradient & RF (PGR) Cabinet.
- Oct 3, 2018 · Class II · Z-0236-2019: A small area on the bore surface, which is normally accessible to the patient, can get warm enough to cause a serious burn in the event the patient touches the bore and proper padding is not used.
- May 11, 2017 · Class II · Z-3024-2017: Possible incorrect wiring of the Uninterruptable Power Supply, which could contribute to a potential shock hazard.
- May 11, 2017 · Class II · Z-3025-2017: Possible incorrect wiring of the Uninterruptable Power Supply, which could contribute to a potential shock hazard.
- May 11, 2017 · Class II · Z-3022-2017: Possible incorrect wiring of the Uninterruptable Power Supply, which could contribute to a potential shock hazard.
- May 11, 2017 · Class II · Z-3023-2017: Possible incorrect wiring of the Uninterruptable Power Supply, which could contribute to a potential shock hazard.
- Jan 20, 2017 · Class II · Z-1188-2017: Potential safety issue with the patient bore heating on the Discovery MR450 narrow bore 1.5T MRI. In the event of a RF component failure, typically happening after extended system use, a small area on

## Indications for use
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 scanners designed to support high resolution, high signal-to-noise ratio, and short scan times. It is indicated for use as a diagnostic imaging device to produce axial, sagittal, coronal, and oblique images, spectroscopic images, parametric maps, and/or spectra, dynamic images of the structures and/or functions of the entire body, including, but not limited to, head, neck, TMJ, spine, breast, heart, abdomen, pelvis, joints, prostate, blood vessels, and musculoskeletal regions of the body. Depending on the region of interest being imaged, contrast agents may be used. The images produced by the Discovery MR750 3.0T, Discovery MR450 1.5T, Discovery MR750w 3.0T and the Optima MR450w 1.5T systems reflect the spatial distribution or molecular environment of nuclei exhibiting magnetic resonance. These images and/or spectra when interpreted by a trained physician yield information that may assist in diagnosis.

Source page: https://510kreport.com/device/K160618
Methodology: https://510kreport.com/methodology