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510(k) Data Aggregation

    K Number
    K100703
    Device Name
    STATIONARY X-RAY SYSTEM (DETECTOR) MODEL: ALTAS
    Manufacturer
    Date Cleared
    2010-12-21

    (284 days)

    Product Code
    Regulation Number
    892.1680
    Why did this record match?
    Applicant Name (Manufacturer) :

    COMED CO., LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The ATLAS is integrated into the user's stationary radiography system. This typical configuration permits a qualified/trained doctor or technologist to take a range of head-to-toe diagnostic radiographic exposures of the skull, spinal column, chest, abdomen, extremities, and other body parts on both adult and pediatric patients. Applications can be performed with patient sitting, standing or lying in the prone or supine positions in an integrated system. The Atlas is not intended for mammography.
    Device Description
    The Atlas is provided high resolution radiographic images in a digital format without use of film, chemistry, cassettes or expensive imaging plates. With 98% of fill factor in each pixel, there is a maximum efficiency and lower dose required for image capture. It has single CCD detector.
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