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510(k) Data Aggregation

    K Number
    K151653
    Device Name
    8ch Foot Ankle Coil
    Date Cleared
    2015-08-07

    (50 days)

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

    SHENZHEN RFTECH CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    8ch Foot Ankle Coil manufactured by RFT is a receive-only RF surface coil designed for use with the SIGNA Pioneer only. 8ch Foot Ankle Coil is indicated to use for foot and ankle imaging. The nucleus excited is hydrogen.
    Device Description
    The 8ch Foot Ankle Coil is a surface coil used for Magnetic Resonance Imaging. It's tuned to image Proton nuclei in a receive-only configuration. It is comprised of 8 individual Phased Array coil elements which receive the signal from patient's foot or ankle. Preamplifiers are integrated in the coil. The geometry is optimized for use with parallel imaging techniques. The 8ch Foot Ankle Coil receives foot or ankle signal through 8-element phased array under 3T static magnetic field and presents the foot or ankle images based on the above mentioned theory. The 8ch Foot Ankle Coil comprises the coil and the base plate. The coil conforms to patients' anatomy, accommodating various foot contours while minimizing patient discomfort. The base plate separated from the coil part is used to place the patients' anatomy on the table. The associated accessories include: - -1 cable - 1 baseplate, - - -1 ankle pad, - -1 foot pad, - 1 ramp pad, - - 1 knee pad support, - - 1 strap. -
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