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510(k) Data Aggregation

    K Number
    K111060
    Device Name
    MRGFUS PELVIC PA COIL MODEL 1.0
    Manufacturer
    INSIGHTECH, LTD
    Date Cleared
    2011-09-09

    (144 days)

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

    INSIGHTECH, LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The MRgFUS Phase Array Pelvic Coil (the MRgFUS PA Coil) is a receive only RF coil, designed for MR imaging of the pelvis and hips. The MRgFUS Coil is designed for use with the GE 1.5 T MRI systems manufactured by GE Medical Systems. The Pelvic Phase Array Coil can be used in conjunction with the InSightec Focused UltraSound (MRgFUS) treatment.
    Device Description
    The MRgFUS Phase Array Pelvic Coil (the MRgFUS PA Coil) is a receive only RF coil, designed for MR imaging of the pelvis and hips.
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