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510(k) Data Aggregation

    K Number
    K143396
    Device Name
    omni TRAX Active Patient Tracker
    Manufacturer
    CIVCO Medical Instruments Co Inc dba CIVCO Medical Solutions
    Date Cleared
    2015-01-23

    (58 days)

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

    CIVCO Medical Instruments Co Inc dba CIVCO Medical Solutions

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The device is intended to provide physicians with a tool for electromagnetic (EM) tracking of instruments with respect to pre-acquired or real-time data. The device is intended for use in Magnetic Resonance Imaging (MRI) and ultrasound (US) environments.
    Device Description
    The proposed device contains multiple fluid-filled cavities that serve as registration points (markers) in MR. Adhesive tape on the bottom of the proposed device is used to secure the device to the patient. Skin marking areas allow for repositioning in both MR and ultrasound environments. The device also provides a connection point for an electromagnetic sensor accessory. The proposed device is provided non-sterile, is intended for single patient use, and is manufactured of non-magnetic materials. The proposed device enables automatic or manual image fusion of real-time ultrasound to previously acquired MR data sets. The proposed device may also be used to aid in image fusion of real-time ultrasound to previously acquired ultrasound data sets.
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