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510(k) Data Aggregation

    K Number
    K133901
    Device Name
    PARI-PATH SURGICAL NAVIGATION SYSTEM
    Manufacturer
    Date Cleared
    2014-06-27

    (189 days)

    Product Code
    Regulation Number
    892.1750
    Why did this record match?
    Applicant Name (Manufacturer) :

    PARITIC INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The pari-path surgical navigation system is a stereotactic accessory for Computed Tomography(CT) and Ultrasound imaging systems. It displays the simulated image of an interventional instrument ( a tracked insertion tool), such as a biopsy needle,an ablation needle ,or probe,on a computer monitor screen that shows an image model of the target organs and the current and the projected future path of the interventional instrument. Ultrasound imaging is incorporated with the pari-path surgical navigation system for the situation in which the target organs may move because of palients's respiratory. It is intended for treatment planning and intra-operative guidance for surgical procedures. It is intended for use in clinical interventionals and for anatomical structures where imaging is currently used for visualizing such procedures.
    Device Description
    The pari-path surgical navigation system is a stereotactic accessory for Computed Tomography(CT) and Ultrasound (US). It utilizes electromagnetic tracking technology to locate and navigate instruments relative to an image model of the patient anatomy. It displays the simulated image of an interventional instrument (a tracked insertion tool). such as a biopsy needle, an ablation needle, or probe, on a computer monitor screen that shows the image model of the patient anatomical target organs and the current and the projected future path of the interventional instrument. The image model of patient anatomical organs is derived from two-dimensional patient images (scan sets) via the navigation system. The interventional instrument can be located and navigated on the image model. Ultrasound imaging is incorporated with the system for the situation in which the target organs may move because of patient's respiratory. The system performs spatial mapping from CT image space to physical space ("registration") to correlate scan sets to the patient. It consists of a magnetic field transmitter, tracking sensors, system unit, monitor, keyboard, mouse, software, and an "off the shelf" ultrasound device (an optional, not supplied with the system).
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