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510(k) Data Aggregation

    K Number
    K113680
    Device Name
    SOMA ACCESS SYSTEMS EXACTTRACK PROCEDURE KIT
    Manufacturer
    SOMA ACCESS SYSTEMS LLC
    Date Cleared
    2011-12-29

    (14 days)

    Product Code
    IYO
    Regulation Number
    892.1560
    Why did this record match?
    Applicant Name (Manufacturer) :

    SOMA ACCESS SYSTEMS LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The device is intended to provide physicians with tools for electromagnetic tracking of instruments with respect to image data.
    Device Description
    The Soma Access Systems ExactTrack™ I Procedure Kit consists of five disposable, sterile components: (1) needle/hub/magnet and needle protective sheath assembly, (2) cable sleeve, (3) elastic bands, (4) top shield assembly, and (5) bottom shield assembly. The needle/hub/magnet assembly consists of the needle, hub, magnet, and needle protective sheath. The needle is 18 gauge stainless steel and accepts a standard guidewire; the hub is an industry standard configuration modified to retain the magnet which is detected by OEM equipment electromagnetic sensors; the needle sheath protects the needle/hub/magnet during packaging and transportation. The cable sleeve is attached at one end to the assembled top and bottom shield by an elastic band and extends over the ultrasound transducer cable to prevent the transducer cable from coming in direct contact with the sterile field. The top and bottom shields' configuration has been designed to snap together while fitting tightly over OEM transducers. The top and bottom shields utilize a needle guide and needle lock during ultrasound procedures.
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