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510(k) Data Aggregation

    K Number
    K113443
    Device Name
    21.3 INCH (54 CM) MONOCHROME LCD MONITOR MS23I2 (ML21023)
    Manufacturer
    TOTOKU ELECTRIC CO., LTD.
    Date Cleared
    2011-12-23

    (32 days)

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

    TOTOKU ELECTRIC CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    21.3 inch (54 cm) Monochrome 2M pixel LCD Monitor MS23i2 (ML21023) is intended 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
    MS23i2 (ML21023) is a 21.3-inch (54 cm) Monochrome LCD monitor whose display resolution is 1200 x 1600 (landscape), 1600 x 1200 (portrait) supporting DVI (digital visual interface) and Display Port.
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    K Number
    K090947
    Device Name
    21.3 (54 CM) MONOCHROME DIGITAL MAMMOGRAPHY LCD MONITOR, MODEL MS3112 (MDL2128A)
    Manufacturer
    TOTOKU ELECTRIC CO., LTD.
    Date Cleared
    2010-08-16

    (500 days)

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

    TOTOKU ELECTRIC CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    21.3 inch (54cm) Monochrome Digital Mammography 3M pixel LCD Monitor with subpixel driving techniques enabling 9M subpixels to be driven independently, MS3112 (MDL2128A) 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
    MS31i2 (MDL2128A) is a 21.3-inch (54 cm) monochrome LCD monitor whose display resolution is 1536 x 6144 (landscape), 6144 x 1536 (portrait) supporting DVI (digital visual interface).
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    K Number
    K081055
    Device Name
    21.3 (54CM) 2M COLOR LCD MONITOR CCL254I2 (CDL2125A)
    Manufacturer
    TOTOKU ELECTRIC CO., LTD.
    Date Cleared
    2008-06-04

    (51 days)

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

    TOTOKU ELECTRIC CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    21.3-inch (54cm) 2M Color LCD Monitor CCL254i2 (CDL2125A) is to be used in displaying and viewing medical images for diagnosis by trained medical practitioners. It is not meant to be used in digital mammography.
    Device Description
    CCL254i2 (CDL2125A) is a 21.3-inch (54cm) 2 megapixel Color LCD monitor that supports DVI video signal and provides UXGA (1200 x 1600) resolution for both landscape and portrait display.
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    K Number
    K081056
    Device Name
    21.3 (54CM) 3M COLOR LCD MONITOR CCL354I2 (CDL2126A)
    Manufacturer
    TOTOKU ELECTRIC CO., LTD.
    Date Cleared
    2008-06-04

    (51 days)

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

    TOTOKU ELECTRIC CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    21.3-inch (54cm) 3M Color LCD Monitor CCL354i2 (CDL2126A) is to be used in displaying and viewing medical images for diagnosis by trained medical practitioners. It is not meant to be used in digital mammography.
    Device Description
    CCL354i2 (CDL2126A) is a 21.3-inch (54cm) 3 meqapixcel Color LCD monitor that supports DVI video signal and provides UXGA (1536 x 2048) resolution for both landscape and portrait display.
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    K Number
    K051403
    Device Name
    19-INCH (48CM) COLOR LCD MONITOR CDL1904A
    Manufacturer
    TOTOKU ELECTRIC CO., LTD.
    Date Cleared
    2005-07-14

    (44 days)

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

    TOTOKU ELECTRIC CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    19-inch (48cm) Color LCD Monitor CDL1904A 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
    CDL1904A is a 19-inch Color LCD Monitor that has a multi-scanning function corresponding to resolution from VGA 640 x 400 to SXGA 1280 x 1024. This is also compliant with VESA standard display mode.
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