# K132376: Discovery MR750 3.0T, Discovery MR450 1.5T, Discovery MR750W 3.0T, Optima MR450W 1.5T

- Pathway: 510(k) (Traditional)
- Applicant: Ge Healthcare (Ge Medical Systems, LLC)
- Decided: Nov 15, 2013 after 108 days
- Product code: LNH (System, Nuclear Magnetic Resonance Imaging)
- Device class: 2
- Regulation: 21 CFR 892.1000
- Recalls of this device: 15 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 11 generations back to K971684 (1997). 28 ancestors in all.
42 later devices descend from it; 2 cite it directly.
5 of 71 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K130115: Discovery MR750W 3.0T, Ge Medical Systems, LLC (2013)
- K123522: Optima MR450W, Ge Healthcare (Ge Medical Systems, LLC) (2013) Summary page 1.

## Most influential descendants
- K142085: Discovery MR750 3.0T ,Discovery MR450 1.5T, Discovery MR750 3.0T,Optima MR450W 1.5T (2014), 40 descendants of its own
- K160618: Discovery MR750 3.0T, Discovery MR450 1.5T, Discovery MR750w 3.0T, Optima MR450w 1.5T (2016), 16 descendants of its own
- 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
- K143345: SIGNA Pioneer (2015), 15 descendants of its own
- K171128: SIGNA Premier (2017), 11 descendants of its own

## Recalls of this device
- 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 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
- 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-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.
- 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
- Jun 8, 2016 · Class II · Z-2131-2016: GE Healthcare has recently become aware of a potential safety issue with the patient bore heating on the Discovery MR750w. A small area on the bore surface, which is normally accessible to the patient
- Dec 7, 2015 · Class II · Z-0201-2019: GE Healthcare has recently become aware of a potential safety issue with the 3.0T 6 Channel Flex Coil used with the 3T MR750W Surgical Suite Scanners. Coil overheating can occur when the device is use
- Aug 31, 2015 · Class II · Z-0254-2016: When performing head or neck scans, the currently displayed SAR values could be lower than the actual SAR in the head as predicted by SAR modeling. The predicted HEAD SAR value from the modeling sugge
- Aug 31, 2015 · Class II · Z-0259-2016: When performing head or neck scans, the currently displayed SAR values could be lower than the actual SAR in the head as predicted by SAR modeling. The predicted HEAD SAR value from the modeling sugge

## 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/K132376
Methodology: https://510kreport.com/methodology