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510(k) Data Aggregation

    K Number
    K020061
    Device Name
    IMAGEDESK
    Manufacturer
    BARCO NV
    Date Cleared
    2002-04-03

    (85 days)

    Product Code
    LLZ
    Regulation Number
    892.2050
    Type
    Traditional
    Panel
    Radiology
    Reference & Predicate Devices
    K001753
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The ImageDesk device is intended to be used in displaying and viewing digital images for review and analysis by trained medical practitioners.

    Device Description

    The ImageDesk device is a digital image display system. The ImageDesk device is a system consisting of components to provide high resolution visualization of digital images.

    AI/ML Overview

    No specific acceptance criteria or details of a study proving the device meets acceptance criteria are provided in the given text.

    The document is a 510(k) summary and FDA clearance letter for a medical imaging display system. It describes the device, its intended use, and confirms substantial equivalence to a predicate device. However, it does not include information about performance studies, acceptance criteria, or specific metrics like accuracy, sensitivity, or specificity that would typically be found in a study proving device performance.

    Therefore, I cannot populate the table or answer the specific questions related to acceptance criteria and study details based on the provided text.

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