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510(k) Data Aggregation

    K Number
    K982690
    Device Name
    BARCO MEDICAL DISPLAY CONFORMITY AND CONSISTENCY SOFTWARE
    Manufacturer
    BARCO NV
    Date Cleared
    1998-10-06

    (64 days)

    Product Code
    LLZ
    Regulation Number
    892.2050
    Type
    Traditional
    Panel
    Radiology
    Reference & Predicate Devices
    K972701
    Predicate For
    K020058,K020073
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Barco MediCal Display Conformity and Consistency Software device is intended to be used as a tool in displaying and viewing digital images for review and analysis by trained medical practitioners.

    Device Description

    The MediCal device is image consistency and calibration software package.

    AI/ML Overview

    I am sorry, but the provided text does not contain information about acceptance criteria, device performance, test study details (sample size, data provenance, expert qualifications, adjudication methods), multi-reader multi-case studies, standalone algorithm performance, ground truth types, or training set specifics. The document is a 510(k) summary for a medical device called "Barco MediCal Display Conformity and Consistency Software," which is image consistency and calibration software. It describes the manufacturer, contact information, classification, intended use, and technological characteristics, as well as the FDA's clearance letter. However, it lacks the detailed performance study information you've requested.

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