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510(k) Data Aggregation

    K Number
    K252179

    Validate with FDA (Live)

    Device Name
    GEM Flex Coil 16-L Array, 1.5T Receive Only; GEM Flex Coil 16-M Array, 1.5T Receive Only; GEM Flex Coil 16-S Array, 1.5T Receive Only
    Manufacturer
    Shenzhen RF Tech Co., Ltd.
    Date Cleared
    2026-02-10

    (214 days)

    Product Code
    MOS
    Regulation Number
    892.1000
    Type
    Traditional
    Panel
    Radiology
    Age Range
    All
    Reference & Predicate Devices
    K113474
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The 1.5T GEM Flex Suite manufactured by Shenzhen RF Tech Co., Ltd. is receive-only coil and is designed for use as general-purpose coil. It includes of three coils: 16-L Array, 16-M Array, and 16-S Array. The 1.5T GEM Flex Suite is designed for use with GEHC 1.5T MRI systems to produce diagnostic images of the Head, Torso, Hip, Spine, Shoulder, Knee, Foot, Ankle, Elbow, and Wrist that can be interpreted by a trained physician.

    Device Description

    The three Coils are receive only phased array coil to produce diagnostic images of the Head, Torso, Hip, Spine, Shoulder, Knee, Foot, Ankle, Elbow, and Wrist.

    The three Coils are tuned to receive RF frequency corresponding to the proton precession in a 1.5 Tesla magnetic field, which is governed by the Larmor equation.

    AI/ML Overview

    N/A

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