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510(k) Data Aggregation

    K Number
    K970136
    Device Name
    DIGITAL ADD-ON BUCKY
    Date Cleared
    1997-11-21

    (310 days)

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

    SWISSRAY TELERAY AG

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Swissray Telleray AG Digital Add-on Bucky system is a high resolution, digital imaging system designed for Digital Photofluorography. It is intended to replace conventional film techniques or dedicated applications where general Radiography and fluoroscopy procedures are performed. The Digital Add-on Bucky is intended for applying general radiography on a patient in a supine, seated, or standing position including tomography examinations. The Digital Add-on Bucky system allows the operator to view and enhance the images may be viewed and enhanced enabling the operator to bring out diagnostic details difficult or impossible to see using conventional imaging techniques. The Add-on Bucky system enables the operator to hardcopy images with a laser printer.
    Device Description
    The major system components include: a CCD camera, monitors and an image processor.
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