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Brivo MR355

by Ge Hangwei Medical Systems Co., Ltd. 510(k)

Active United States

510(k) K120778

Overview

The Brivo MR355 is a 1.5T whole body magnetic resonance scanner designed to support high resolution, high signal-to-noise ratio, and short scan times. It functions as a diagnostic imaging device for medical applications.

The device is manufactured by GE Hangwei Medical Systems Co., Ltd. and has received FDA 510(k) clearance with the K number K120778. It is classified as a Class II device and regulated under code 892.1000 for Nuclear Magnetic Resonance Imaging systems.

AI-generated from registry data, 6 Oct 2026.Not verified by deviCERTS or the manufacturer

Regulatory status

as of 27 Oct 2026

Recall ongoing. 3 ongoing FDA recalls. See recalls

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Special NumberK120778 Date27 Mar 2012ClearedStatusActive

Coverage

1 jurisdiction

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

United States — FDA 510(k) Active

Recalls

4 recalls · 3 ongoing · FDA

  • 2 recalls, same reason

    • Ongoing Z-2477-2024 FDA Class II initiated 14 Jun 2024
    • Ongoing Z-2478-2024 FDA Class II initiated 14 Jun 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 are met: 1. 2D FSE T2 FLAIR OR T2 FLAIR Propeller imaging sequence is selected, AND 2. the Optimized T2 FLAIR sequence option is turned off OR not included in the MR configuration. If this occurs, it can result in overheating of an MR conditional implant.

    • Ongoing Z-0611-2022 FDA Class II initiated 23 Dec 2021

    The magnetic resonance systems could potentially have a cryogen ventilation system that does not meet the venting requirements.

    • Terminated Z-3021-2017 FDA Class II initiated 11 May 2017

    Possible incorrect wiring of the Uninterruptable Power Supply, which could contribute to a potential shock hazard.

Specification

510(k)

510(k) Number
FDA Product Code
LNH
Device Class
Class II
Regulation
21 CFR Part 892.1000
Advisory Committee
Radiology
FDA Decision
SESE Substantially Equivalent

Other devices from Ge Hangwei Medical Systems Co., Ltd.

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Questions

  • What is the BRIVO MR355 used for?

    The BRIVO MR355 is a diagnostic imaging device designed for medical applications. It functions as a whole body magnetic resonance scanner that supports high resolution imaging, high signal-to-noise ratio, and short scan times to aid in medical diagnosis.

  • What is the regulatory status of the BRIVO MR355?

    The BRIVO MR355 has received FDA 510(k) clearance with K number K120778. It is classified as a Class II device and regulated under code 892.1000 for Nuclear Magnetic Resonance Imaging systems. The device was found to be substantially equivalent to predicate devices.

  • Who manufactures the BRIVO MR355?

    The BRIVO MR355 is manufactured by GE Hangwei Medical Systems Co., Ltd., located in Beijing, China. The company received FDA clearance for this device on March 27, 2012, after the application was received on March 14, 2012.

  • What are the key specifications of the BRIVO MR355?

    The BRIVO MR355 is a 1.5T whole body magnetic resonance scanner designed to support high resolution imaging, high signal-to-noise ratio, and short scan times. It functions as a diagnostic imaging device for medical applications, providing detailed anatomical and functional information.