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510(k) Data Aggregation

    K Number
    K090732
    Device Name
    NIO COLOR 3MP AND MDNC-3121
    Manufacturer
    BARCO NV
    Date Cleared
    2009-04-20

    (32 days)

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

    The MDNC-3121 Medical Flat Panel Display System is intended to be used in displaying and viewing digital images for review by trained medical practitioners. These devices must not be used in primary image diagnosis in mammography. The MDNC-3121, which is part of the Nio Color 3MP system, will be marketed separately.

    Device Description

    Nio Color 3MP (MDNC-3121) Medical Flat Panel Display System

    AI/ML Overview

    This document is a 510(k) clearance letter from the FDA for a medical display monitor (Nio Color 3MP). It does not contain information about acceptance criteria or a study proving that a device (specifically an AI/algorithm-based diagnostic device) meets such criteria.

    The information requested in your prompt (e.g., sample sizes, expert qualifications, ground truth methods, MRMC studies, training set details) is typically found in clinical study reports or scientific publications that support the efficacy and safety of an algorithm-based medical device. This document concerns hardware (a display monitor) and its substantial equivalence to previously marketed devices, based on its intended use as a display for reviewing digital images, not for primary image diagnosis in mammography.

    Therefore, I cannot extract the requested information from the provided text.

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