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510(k) Data Aggregation

    K Number
    K033104
    Manufacturer
    Date Cleared
    2004-04-19

    (203 days)

    Product Code
    Regulation Number
    892.2050
    Reference & Predicate Devices
    Why did this record match?
    Device Name :

    MGD 2621P MEDICAL GREYSCALE DISPLAY

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The MGD 2621P Medical Grayscale Display is intended to be used as a tool in displaying and viewing digital images (excluding digital mammography) for review and analysis by trained medical practitioners.

    Device Description

    The MGD 2621P is a diagnostic display

    AI/ML Overview

    The provided text is a 510(k) summary for the Barco MGD 2621P Medical Grayscale Display. This document does not contain the information requested in points 1-9 regarding acceptance criteria and a study proving the device meets these criteria.

    The 510(k) summary focuses on general device information, intended use, and substantial equivalence to a predicate device (Barco MGD 221 2 Megapixel Diagnostic Display - K000293). It describes the device's technical characteristics as a high-resolution monitor with electronic capabilities for evaluating high-resolution medical images.

    The letter from the FDA confirms market clearance based on substantial equivalence but does not delve into specific performance studies or acceptance criteria for the display itself. It mainly cites relevant regulations and guidelines for the manufacturer.

    Therefore, I cannot provide the requested table or answer questions 1-9 based on the input text. The document is essentially a regulatory clearance notice, not a detailed performance study report.

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