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510(k) Data Aggregation

    K Number
    K113280
    Device Name
    CAROTID COIL GE 1.5T
    Date Cleared
    2011-11-23

    (16 days)

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

    TURSIOP TECHNOLOGIES LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Carotid Coil GE1.5T is a receive-only 2-channel diagnostic MR imaging coil designed for use at a static magnetic field strength of 1.5T with the GE Twinspeed HDx 1.5T MRI scanner/system. It is used for obtaining diagnostic images of the carotid arteries in the region of the neck and lower cranium.
    Device Description
    The Carotid Coil GE1.5T is a receive-only 2-channel coil for operation at a magnetic field strength of 1.5T with the GE Twinspeed HDx system. The coil is a two-element coil consisting of two independent rectangular loops, each of approximate size 7 cm x 4.5 cm. Coupling of either coil element to the transmitted field is prevented through respective active blocking circuits. The Carotid Coil GE1.5T is specially designed for MR imaging of the carotid arteries in the region of the neck and lower cranium. The coil provides optimum signal to noise ratio and coverage in the area of the carotid arteries, allowing high-resolution imaging, while the sensitive region of the coil covers an approximately 7 cm Field of View.
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    K Number
    K083434
    Device Name
    TT1 GENERAL PURPOSE COIL
    Date Cleared
    2008-12-23

    (33 days)

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

    TURSIOP TECHNOLOGIES LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The TT1 General Purpose Coil is a receive-only diagnostic MR imaging coil designed for use at a static magnetic field strength of 1.5T with the GE Signa® 1.5T system. It is used for obtaining diagnostic images of a variety of small-to-medium sized anatomical regions, such as jaw, spine, neck, shoulder, thigh, foot, ankle and joints.
    Device Description
    The TT1 General Purpose Coil is a linear receive-only coil for operation at a magnetic field strength of 1.5T with the GE Signa® 1.5T system. The coil is a single element coil consisting of a 3-inch diameter loop. Coupling of the coil to the transmitted field is prevented through an active blocking circuit. The TT1 General Purpose Coil is specially designed for MR imaging of small-to-medium sized anatomical regions, such as jaw, spine, neck, shoulder, thigh, foot, ankle and joints. The coil provides optimum signal to noise ratio and coverage, allowing high-resolution imaging, while the sensitive region of the coil covers an approximately a 10 cm Field of View.
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