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    K Number
    K033066
    Device Name
    XISCAN 4000 TRANSPORTABLE IMAGING SYSTEM
    Manufacturer
    XITEC HOLDINGS LLC.
    Date Cleared
    2003-11-12

    (44 days)

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

    XITEC HOLDINGS LLC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The XiScan 4000 Transportable Imaging System is intended for fluoroscopic imaging of patient extremities.
    Device Description
    The XiScan 4000 Transportable Imaging System is a compact, mobile, mini C-arm system specifically designed for fluoroscopic imaging of patient extremities. The XiScan 4000 Imaging System can be operated in either manual or automatic exposure rate control (AERC) modes, with options of reduced radiation LOW DOSE and high resolution STANDARD DOSE when using AERC. The XiScan 4000 offers a range of functions for image manipulations. It features touchscreen controls to manage on-screen patient information and image storage.
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