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510(k) Data Aggregation

    K Number
    K970136
    Device Name
    DIGITAL ADD-ON BUCKY
    Manufacturer
    SWISSRAY TELERAY AG
    Date Cleared
    1997-11-21

    (310 days)

    Product Code
    KPR
    Regulation Number
    892.1680
    Type
    Traditional
    Panel
    Radiology
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    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.

    AI/ML Overview

    I am sorry, but the provided text does not contain the acceptance criteria or a study proving device performance as requested. The document is a 510(k) clearance letter from the FDA for a device called "Swissary Telleray AG Digital Add-on Bucky System." It states that the device is substantially equivalent to legally marketed predicate devices and outlines regulatory information and contact details. It does not include specific performance metrics, study details, or ground truth information.

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