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510(k) Data Aggregation

    K Number
    K063066
    Device Name
    AXIS-V MONOCHROME 5 MP DISPLAY
    Manufacturer
    NATIONAL DISPLAY SYSTEMS
    Date Cleared
    2007-08-03

    (301 days)

    Product Code
    LLZ
    Regulation Number
    892.2050
    Type
    Traditional
    Panel
    Radiology
    Reference & Predicate Devices
    K042221,K042755
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The AXIS-V 5MP Radiological Monochrome Medical Display is intended to be used to display and view digital images, including digital mammography, for review and analysis by trained medical practitioners.

    Device Description

    The AXIS-V 5MP Monochrome Display is a diagnostic display.
    The AXIS-V 5MP Monochrome Display is a high-resolution Liquid Crystal Display (LCD) with electronic capabilities used for the review and analysis of high-resolution medical images by trained medical practitioners.

    AI/ML Overview

    The provided text is a 510(k) summary for a medical display device, the AXIS-V 5MP Monochrome Display. It does not contain information about acceptance criteria, study data, sample sizes, expert ground truth establishment, or any comparative effectiveness studies as requested in your prompt. This document serves as a regulatory submission for premarket notification, establishing substantial equivalence to existing devices rather than detailing performance study outcomes.

    Therefore, I cannot extract the requested information from the provided text. The document primarily focuses on:

    • Manufacturer and Contact Information: National Display Systems, LLC.
    • Device Description: AXIS-V 5MP Monochrome Display, a high-resolution Liquid Crystal Display (LCD) for viewing medical images, including digital mammography.
    • Intended Use: To display and view digital images for review and analysis by trained medical practitioners.
    • Classification and Product Code: 21 CFR 892.2050/Procode 90LLZ (Picture archiving and communications system).
    • Substantial Equivalence: Claimed against Coronis 5MP (Barco) K042221 and RadiForce G51 (Eizo Nanao) K042755.
    • FDA Communication: A letter from the FDA acknowledging review of the 510(k) and determining substantial equivalence, allowing the device to be marketed under general controls.

    To provide the information you're looking for, I would need a different document, such as a clinical study report, a detailed performance evaluation report, or a more comprehensive technical submission that outlines the testing and validation performed on the device.

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