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    K Number
    K012379
    Device Name
    PDX-2000 PORTABLE DIGITAL X-RAY SYSTEM
    Manufacturer
    TREX ENTERPRISES CORP.
    Date Cleared
    2001-08-16

    (21 days)

    Product Code
    IZLPRE
    Regulation Number
    892.1720
    Why did this record match?
    Applicant Name (Manufacturer) :

    TREX ENTERPRISES CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The PDX-2000 Portable Digital X-Ray System provides digital image capture for conventional film/screen radiographic examinations. The device is intended to replace radiographic film/screen systems in all general purpose diagnostic procedures.
    Device Description
    The PDX-2000 Portable Digital X-ray System consists of a Canon X-ray digital camera CXDI-22 retrofit kit, a MinXray Portable Source Generator and Trex proprietary adaptations. The PDX-2000 provides diagnostic images for general radiography with portable table and upright system.
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