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510(k) Data Aggregation

    K Number
    K173736
    Device Name
    TrackX
    Date Cleared
    2018-02-28

    (84 days)

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

    TrackX Technology, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    TrackX is intended for use in any application where a fluoroscope is incorporated to aid in diagnosis and treatment of disease.
    Device Description
    TrackX is a software application which captures diagnostic images using 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. Instrument tracking is accomplished using either an electromagnetic or optical tracking system with one tracker mounted on the surgical instrument and another tracker mounted on the fluoroscope. When used with an electromagnetic tracking system. Civco's eTRAX Needle Tip Tracking system is used. When used with an optical tracking system. TrackX snaps are used. The tracking information is then fed into the TrackX software which manipulates the location of an X-ray image based on movement of the tracked surgical instrument tracking aids the physician in repositioning their surgical instruments by providing visual feedback on where they have moved their instruments between X-ray images. Additionally, TrackX can register the current image being taken (which contains the surgical instrument) with a prior Baseline image of the same anatomy and then use the Baseline image as a Background which the current image is translated over as part of instrument tracking. TrackX can be used with either electromagnetic tracking or optical tracking. The C-arm tracking feature of the predicate device creates a viewfinder for the fluoroscope which allows the user to track the C-arm movement as they localize and relocalize the fluoroscope during an intervention. While TrackX does not provide this feature, it is still necessary to mount components to the Carm so that its position can be tracked. The C-arm's tracked position is used to detect the Carm's orientation and to track the position of instruments relative to the C-arm.
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