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510(k) Data Aggregation

    K Number
    K071966
    Device Name
    1.5T MRGFUS PELVIC COIL
    Manufacturer
    INSIGHTEC-TXSONICS, INC.
    Date Cleared
    2007-09-05

    (51 days)

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

    INSIGHTEC-TXSONICS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Pelvic Array Coil is a receive only phased array RF coil used for obtaining diagnostic images of the pelvis, including the hips, in magnetic resonance imaging systems. The Pelvic Array Coil is designed for use with the GE 1.5T MRI systems manufactured by GE Medical Systems. The Pelvic Array Coil can be used in conjunction with the InSightec Focused UltraSound (FUS) treatment.
    Device Description
    The MRgFUS Pelvic Array Coil is a receive-only, quadrature phased array RF coil, used for obtaining diagnostic MR images of the pelvis, including the hips. The elements and associated circuitry are enclosed in both rigid and semi-flexible housing that is fire rated and has a high impact and tensile strength.
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