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510(k) Data Aggregation

    K Number
    K050617
    Device Name
    21.3-INCH (54CM) MONOCHROME LCD MONITOR, MODELS MDL2109A, ME251I & DV2MM-HB
    Manufacturer
    TOTOKU ELECTRIC CO., LTD
    Date Cleared
    2005-04-22

    (43 days)

    Product Code
    LLZ
    Regulation Number
    892.2050
    Type
    Traditional
    Panel
    Radiology
    Reference & Predicate Devices
    K040695
    Why did this record match?
    Device Name :

    21.3-INCH (54CM) MONOCHROME LCD MONITOR, MODELS MDL2109A, ME251I & DV2MM-HB

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

    21.3-inch (54cm) Monochrome LCD Monitor MDL2109A (ME251i) (DV2MM-HB) is to be used in conjunction with the picture archiving communication system (PACS) for medical imaging applications. It is not meant to be used for digital mammography.

    Device Description

    MDL2109A (ME251i) (DV2MM-HB) is a 21.3-inch Monochrome LCD Monitor that supports DVI video signal and provides UXGA (1200 x 1600) resolution for both landscape and portrait display.

    AI/ML Overview

    The provided document is a 510(k) summary and FDA approval letter for a monochrome LCD monitor. It does not contain information about acceptance criteria and a study proving the device meets those criteria. The document focuses on establishing substantial equivalence to a predicate device and its intended use.

    Therefore, I cannot provide the requested information.

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