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510(k) Data Aggregation

    K Number
    K200360
    Device Name
    TrackX
    Date Cleared
    2020-03-05

    (21 days)

    Product Code
    Regulation Number
    892.1650
    Why did this record match?
    Applicant Name (Manufacturer) :

    Track X Technology, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    TrackX v.2.0 is intended for use in any application where a fluoroscope is incorporated to aid in the diagnosis and treatment of disease.
    Device Description
    TrackX is a software application which captures diagnostic images from a fluoroscope via a video cable. In addition, TrackX interfaces with an off-the-shelf tracking system in order to track the position of surgical instruments relative to the fluoroscope. The user controls and views information via a primary monitor. The viewing monitor is not part of the subject device. TrackX will track the location of the tip of a surgical instrument. TrackX works by translating and rotating an X-ray image which contains the surgical instrument on the screen based on the surgeon's movement of the instrument. This real-time feedback allows the physician to reposition the instrument with greater accuracy between X-ray images. This aids the physician in repositioning their surgical instruments by providing visual feedback on where they have moved their instruments between X-ray images.
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