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510(k) Data Aggregation

    K Number
    K081242
    Device Name
    21.3 INCH (53CM) MONOCHROME DIGITAL MAMMOGRAPHY LCD MONITOR MS51I2, (MDL2123A)
    Manufacturer
    TOKOTU ELECTRIC CO., LTD.
    Date Cleared
    2008-06-11

    (41 days)

    Product Code
    LLZ
    Regulation Number
    892.2050
    Why did this record match?
    Applicant Name (Manufacturer) :

    TOKOTU ELECTRIC CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    21.3 inch (53cm) Monochrome Digital Mammography 5M pixel LCD Monitor with subpixel driving techniques enabling 15M subpixels to be driven independently. MS51i2 (MDL2123A) is intended to be used in displaying and viewing medical images for diagnosis by trained medical practitioners. It is to be used in digital mammography PACS and modalities including FFDM.
    Device Description
    MS51i2 (MDL2123A) is a 21.3-inch (53 cm) monochrome LCD monitor whose display resolution is 2048 x 7680 (landscape), 7680 x 2048 (portrait) supporting DVI (digital visual interface).
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    K Number
    K061061
    Device Name
    20.1-INCH (51CM) COLOR LCD MONITOR CDL2009A (CCL204)
    Manufacturer
    TOKOTU ELECTRIC CO., LTD.
    Date Cleared
    2006-06-07

    (51 days)

    Product Code
    LLZ
    Regulation Number
    892.2050
    Why did this record match?
    Applicant Name (Manufacturer) :

    TOKOTU ELECTRIC CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    20.1-inch (51cm) Color LCD Monitor CDL2009A (CCL204) is to be used in displaying and viewing medical images for diagnosis by trained medical practitioners. It is not meant to be used for digital mammography.
    Device Description
    CDL2009A has a multi-displaying function corresponding to the resolution from VGA 640 x 480 to UXGA 1600 x 1200. This is also compliant with VESA standard display mode.
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