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510(k) Data Aggregation

    K Number
    K052200
    Device Name
    TEM 3000 HEAD COIL
    Manufacturer
    MR INSTRUMENTS INC.
    Date Cleared
    2005-08-19

    (7 days)

    Product Code
    MOS
    Regulation Number
    892.1000
    Why did this record match?
    Applicant Name (Manufacturer) :

    MR INSTRUMENTS INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The MR Instruments TEM 3000G Head Coil is designed to provide Magnetic Resonance Images of the brain, soft tissues and vasculature of the head. The TEM 3000G Head Coil is designed for use with the GE Signa 3.0T Excite MR System manufactured by GE.
    Device Description
    The TEM 3000G Head Coil is a 15-element, quadrature transmit/receive coil. The coil elements and associated circuitry are enclosed in a rigid housing to prevent rne exposure to patient or environment. The coil housing employs a large open any order on the top. The coil design facilitates the scanning of patients with different head sizes and maximizes patient comfort and ease of use.
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