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510(k) Data Aggregation

    K Number
    K024085
    Device Name
    CCD CAMERA, MODEL PKP-06000-000
    Date Cleared
    2003-03-11

    (90 days)

    Product Code
    Regulation Number
    892.1620
    Why did this record match?
    Applicant Name (Manufacturer) :

    PERKINS ELECTRONICS CO.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    This Device is a Charged Coupled Device (CCD) camera for use in digital radiography, including DSA, high-resolution cardiology, and low dose fluoroscopy. It is designed for use with X-Ray image intensifiers in diagnostic imaging chains. The purpose of this device is to convert the visible image at the output of the X-Ray system image intensifier, to a video signal for display on a TV monitor.
    Device Description
    This Device is a Charged Coupled Device (CCD) camera for use in digital radiography, including DSA, high-resolution cardiology, and low dose fluoroscopy. It is designed for use with X-Ray image intensifiers in diagnostic imaging chains. The purpose of this device is to convert the visible image at the output of the X-Ray system image intensifier, to a video signal for display on a TV monitor.
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