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510(k) Data Aggregation

    K Number
    K061715
    Device Name
    MRGFUS GENERAL PURPOSE AND BREAST COIL
    Date Cleared
    2006-07-28

    (39 days)

    Product Code
    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 MRgFUS General Purpose and Breast Coil (the MRgFUS Coil) is a receive only RF coil, designed for MR imaging of the breast and auxiliary tissue and of a variety of medium sized anatomical regions, such as spine, neck, shoulder, thigh, foot ankle and joints. The MRgFUS Coil is designed for use with the GE Signa™ (1.5 T or 3.0 T) MRI systems manufactured by GE Medical Systems.
    Device Description
    The MRgFUS Coil is a receive only coil. The coil is a single element coil consisting of two 6.5 inch loops located one above the other and connected electrically in parallel. Coupling of the coil to the transmitted field is prevented through three RF blocking circuits, one active and two passive circuits. There are two versions of the MRgFUS Coil, one compatible with 1.5 T MRI and the other with 3.0T MRI, providing operating frequency of 63.8 MHz and 127.6 MHz, respectively. This difference in the operating frequency dictates different components value (i.e. capacitors and inductors). Another difference is the coil connector, which is dictated by the MRI coil interface. In all other aspects, the two coil versions are identical. The MRgFUS Coil is specially designed for MR imaging of variety of anatomic regions including the human female breast in conjunction with a Focused UltraSound (FUS) treatment employing MR thermometry to monitor temperature. The coil provides optimum signal to noise ratio and coverage, allowing high-resolution imaging, while the sensitive region of the coil covers approximately a 15 cm Field of View.
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