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510(k) Data Aggregation

    K Number
    K122298
    Device Name
    AJEX 1200 H / AJEX 240H MOBILE X-RAY GENERATOR
    Date Cleared
    2014-03-28

    (605 days)

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

    AJEX MEDITECH., LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    This equipment is used for generating X-ray to get the X-ray image for the purpose of diagnosis of patient. This equipment is possible to move the place for patient because it is designed for portable type. This equipment is possible to combine with the mobile stand unit for convenience for patient positioning according to user's needs. The AJEX 1200H/ AJEX 240H Mobile X-ray Generator is designed for the following applications : - Physician with general practice - Bedside exposures in hospital ward - Surgery and Orthopedics
    Device Description
    The AJEX 1200H and AJEX 240H are portable x-ray units which operate at 110V or 220V, 50/60 HZ. The units have an LED display with up and down soft keys to control KvP. In addition the unit has preset memory keys to store and select KvP. The units can be installed on a mobile stand, a support arm or can be hand held. The unit should be used only by qualified/trained doctor or technician on both adult and pediatric subjects for taking diagnostic radiographic exposures of body parts. The usual safety precautions regarding the use of x-ray units must be observed by the operator.
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