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510(k) Data Aggregation

    K Number
    K252371

    Validate with FDA (Live)

    Device Name
    uMR 680
    Manufacturer
    Shanghai United Imaging Healthcare Co., Ltd.
    Date Cleared
    2025-09-25

    (57 days)

    Product Code
    LNH,MOS,QIH
    Regulation Number
    892.1000
    Type
    Special
    Panel
    Radiology
    Reference & Predicate Devices
    K243397
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The uMR 680 system is indicated for use as a magnetic resonance diagnostic device (MRDD) that produces sagittal, transverse, coronal, and oblique cross sectional images, and spectroscopic images, and that display internal anatomical structure and/or function of the head, body and extremities.

    These images and the physical parameters derived from the images when interpreted by a trained physician yield information that may assist the diagnosis. Contrast agents may be used depending on the region of interest of the scan.

    Device Description

    The uMR 680 is a 1.5T superconducting magnetic resonance diagnostic device with a 70cm size patient bore. It consists of components such as magnet, RF power amplifier, RF coils, gradient power amplifier, gradient coils, patient table, spectrometer, computer, equipment cabinets, power distribution system, internal communication system, and vital signal module etc. The uMR 680 Magnetic Resonance Diagnostic Device is designed to conform to NEMA and DICOM standards.

    This special 510(k) is to request modifications for the cleared uMR 680(K243397). The modifications performed on the uMR 680 in this submission are due to the following changes that include:

    (1) Addition of RF coils: Tx/Rx Head Coil.
    (2) Addition of a mobile configuration.

    AI/ML Overview

    N/A

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