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510(k) Data Aggregation

    K Number
    K111989
    Device Name
    CORONIS FUSION 4MP DL
    Manufacturer
    BARCO NV
    Date Cleared
    2011-09-22

    (71 days)

    Product Code
    LLZ
    Regulation Number
    892.2050
    Type
    Special
    Panel
    Radiology
    Reference & Predicate Devices
    N/A
    Predicate For
    K143157
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Coronis Fusion 4MP DL (MDCC-4130) is intended to be used in displaying and viewing digital images, for review and analysis by trained medical practitioners. These devices must not be used in primary image diagnosis in mammography.

    Device Description

    Not Found

    AI/ML Overview

    This document is a 510(k) clearance letter for the Barco Coronis Fusion 4MP DL (MDCC-4130) display device. It is a regulatory approval, not a study report. Therefore, it does not contain the information requested about acceptance criteria and a study proving device performance in the context of an AI/algorithm-based medical device.

    The requested information pertains to studies typically performed for AI/ML-driven medical devices to demonstrate their diagnostic performance. This document, however, is for a display device (a monitor) and its clearance is based on demonstrating substantial equivalence to a legally marketed predicate device, primarily focusing on its ability to display digital images for review.

    Therefore, I cannot extract the requested information as it is not present in the provided text.

    To provide an answer to your request, I would need a different type of document, such as a clinical study report or a 510(k) submission summary for an AI/algorithm device that analyzes medical images.

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