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510(k) Data Aggregation

    K Number
    K082347
    Device Name
    DIGITAL RADIOGRAPHY, FLEXDR C30
    Manufacturer
    KONICA MINOLTA TECHNOPRODUCT CO., LTD.
    Date Cleared
    2008-11-18

    (95 days)

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

    KONICA MINOLTA TECHNOPRODUCT CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The device is intended for use for medical purpose in a hospital, etc., in order to convert X-ray image data to digital signal and to transfer the converted data to printer, filing system, image display device, etc. Flex DR C30 is not intended for use with FFDM systems.
    Device Description
    FlexDR C30 is comprised of a reader and an elevator stand that raises and lowers the reader. The reader is an X-ray image reader with a built-in FPD as an X-ray detector. This reader is linked to the exposure liming of the X-ray generator and starts reading of the X-ray image immediately after exposure. The read images are stored inside, and then they are converted one by one to digital data and sent to Medical Image Working Station, CS-3000, 510(k) cleared, K051523. The operator can manually adjust the height of the reader to match the height of the patient by holding the reader elevation handle at the rear of the reader.
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