# K123417: Brivo MR355, Optima MR360

- Pathway: 510(k) (Traditional)
- Applicant: Ge Hangwei Medical Systems Co., Ltd.
- Decided: Jan 17, 2013 after 72 days
- Product code: LNH (System, Nuclear Magnetic Resonance Imaging)
- Device class: 2
- Regulation: 21 CFR 892.1000
- Recalls of this device: 6 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 10 generations back to K971684 (1997). 27 ancestors in all.
5 later devices descend from it; 2 cite it directly.
5 of 33 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K103330: Brivo MR355, Optima MR360, Ge Hangwei Medical Systems Co., Ltd. (2011) Summary page 1.
- K103327: Discovery MR750W 3.0T, Ge Healthcare Japan Corporation (2011) Summary page 1.

## Most influential descendants
- K143251: SIGNA Creator, SIGNA Explorer (2015), 3 descendants of its own
- K211980: SIGNA Prime (2022), 2 descendants of its own
- K223439: SIGNA Victor (2023), 1 descendant of its own
- K250379: SIGNA Prime Elite (2025), 0 descendants of its own
- K223203: 1.5T 24E Posterior Array (2023), 0 descendants of its own

## Recalls of this device
- Jan 31, 2025 · Class II · Z-1240-2025: For certain MR systems, a scan can be resumed following a Power Monitor trip when the "6-minute average SAR" is above the limit indicated on the "SAR Display". The user interface may incorrectly enabl
- Jan 31, 2025 · Class II · Z-1241-2025: For certain MR systems, a scan can be resumed following a Power Monitor trip when the "6-minute average SAR" is above the limit indicated on the "SAR Display". The user interface may incorrectly enabl
- Jun 14, 2024 · Class II · Z-2478-2024: 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-2477-2024: 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-0610-2022: The magnetic resonance systems could potentially have a cryogen ventilation system that does not meet the venting requirements.
- May 11, 2017 · Class II · Z-3021-2017: Possible incorrect wiring of the Uninterruptable Power Supply, which could contribute to a potential shock hazard.

## Indications for use
1.5T Brivo MR355 and I1.5T Optima MR360 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 df 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 1.5T Brivo MR355 and I .5T Optima MR360 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/K123417
Methodology: https://510kreport.com/methodology