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510(k) Data Aggregation
K Number
K200360Device Name
TrackX
Manufacturer
Date Cleared
2020-03-05
(21 days)
Regulation Number
892.1650Why 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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