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510(k) Data Aggregation

    K Number
    K122697
    Device Name
    PORTA 100HF
    Manufacturer
    JOB CORPORATION
    Date Cleared
    2012-10-05

    (31 days)

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

    JOB CORPORATION

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    PORTA 100HF is intended for use by a qualified/trained physician or technician on both adult and pediatric subjects for taking diagnostic X-rays.
    Device Description
    PORTA 100HF is an X-ray unit which operates from AC100-120V/15A or AC200-240V/10A. The device consists of the control panel with the kV and mAs selectors (a rotary switch system) and display for radiographic operations, and the APR switch with 8 memory settings (kV/mAs) to store the exposure data. The device also consists of the X-ray tube, the collimator, power code, and the hand switch, comprising the mono-tank type of a portable X-ray unit. The unit utilizes a high frequency inverter designed to be mounted on a stand. The device can be used with conventional X-ray film or digital imaging media. The usual safety precautions regarding X-rays must be observed by the operator.
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