# K120778: Brivo MR355

- Pathway: 510(k) (Special)
- Applicant: Ge Hangwei Medical Systems Co., Ltd.
- Decided: Mar 27, 2012 after 13 days
- Product code: LNH (System, Nuclear Magnetic Resonance Imaging)
- Device class: 2
- Regulation: 21 CFR 892.1000
- Recalls of this device: 4 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 9 generations back to K971684 (1997). 25 ancestors in all.
No later device cites it as a predicate yet.
5 of 26 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.

## Recalls of this device
- 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-0611-2022: 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
The Brivo MR355 is a whole body magnetic resonance scanner 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 flmctions 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 Brivo MR3 55 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/K120778
Methodology: https://510kreport.com/methodology