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510(k) Data Aggregation

    K Number
    K003568
    Device Name
    XISCAN 6000 IMAGING SYSTEM
    Manufacturer
    XITEC, INC.
    Date Cleared
    2000-12-27

    (37 days)

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

    XITEC, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Device Description
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    K Number
    K984406
    Device Name
    XISCAN OFFICE EXPERT IMAGING SYSTEM, XISCAN SURGICAL EXPERT IMAGING SYSTEM
    Manufacturer
    XITEC, INC.
    Date Cleared
    1999-02-02

    (55 days)

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

    XITEC, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The XiScan Expert Imaging Systems are intended for fluoroscopic imaging of patient extremities.
    Device Description
    The XiScan Expert Imaging Systems are compact, mobile, mini c-arm systems specifically designed for fluoroscopic imaging of patient extremities. Two versions are available: the XiScan Office Expert and the XiScan Surgical Expert. The systems 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. Both systems offer a range of options for image manipulations. The Surgical Expert also features a remote, hand-held keypad to manage on-screen patient information and image storage.
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