# K103330: Brivo MR355, Optima MR360

- Pathway: 510(k) (Traditional)
- Applicant: Ge Hangwei Medical Systems Co., Ltd.
- Decided: Feb 11, 2011 after 91 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: 8 generations back to K971684 (1997). 24 ancestors in all.
7 later devices descend from it; 2 cite it directly.
5 of 32 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K052978: GE 1.5T Signa Hde MR System, Ge Medical Systems, LLC (2005) Summary page 1.
- K083147: Discovery MR450, Ge Medical Systems, LLC (2008) Summary page 1.

## Most influential descendants
- K123417: Brivo MR355, Optima MR360 (2013), 5 descendants of its own
- 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

## 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-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.
- Jun 8, 2012 · Class II · Z-1209-2013: GE Healthcare has recently become aware of a Reformat Image Flip Issue associated with GE MR Products. The axial and coronal reformatted images from a sagittal 3D series (such as with applications of 
- Nov 9, 2010 · Not classified · Z-1433-2011: GE Healthcare has become aware of a potential issue associated with the gradient cables being inadvertently swapped while servicing the gradients on some GE Healthcare MR Systems that may impact patie

## Indications for use
The Brivo MR355/ Optima MR360 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 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 Brivo MR355/ 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/K103330
Methodology: https://510kreport.com/methodology