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    K Number
    K211423
    Device Name
    Rover
    Manufacturer
    Micro-X Limited
    Date Cleared
    2021-05-21

    (14 days)

    Product Code
    IZL, LLZ, MQB
    Regulation Number
    892.1720
    Why did this record match?
    Applicant Name (Manufacturer) :

    Micro-X Limited

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The device is designed to perform radiographic x-ray examinations on pediatric and adult patient treatment areas.
    Device Description
    The Rover product concept was developed under a contract from the Australian Department of Defense to fulfil a need for a full performance digital medical x-ray imager, light enough to be used in deployed medical facilities. Key Design Features: Full trauma imaging capability 40-110kV, 0.2-20mAs; Ultra-light weight at 105 kg; Ground Clearance allows for 75mm step up; Operation on uneven ground; Spare battery tray swap out in under a minute; The unit uses FDA cleared digital image capture panels and software made by FujiFilm OR Varex.
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