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510(k) Data Aggregation

    K Number
    K020073
    Device Name
    MEDICAL ADMINISTRATOR
    Manufacturer
    BARCO NV
    Date Cleared
    2002-07-12

    (184 days)

    Product Code
    LLZ
    Regulation Number
    892.2050
    Type
    Traditional
    Panel
    Radiology
    Reference & Predicate Devices
    K982690
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The MediCal Administrator device is intended to be used as a tool for trained medical practitioners to manage total image softcopy quality from a central location.

    Device Description

    The MediCal Administrator device is a digital image quality management system

    AI/ML Overview

    The provided text is a 510(k) summary for the Barco MediCal Administrator, a digital image quality management system. It contains information about the device's intended use and classification, but it does not include any information regarding acceptance criteria, performance studies, sample sizes, ground truth establishment, or expert involvement.

    Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on the provided input. The document merely states that the device is substantially equivalent to a legally marketed predicate device (K982690) and clears it for marketing.

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