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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
    K113136
    Device Name
    21.3INCH (54CM)COLOR LCD MONITOR CCL256I2(CL21256)
    Manufacturer
    TOTOKU ELECTRIC CO., LTD
    Date Cleared
    2011-12-20

    (57 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) Color 2M pixel LCD Monitor CCL256i2 (CL21256) is intended 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
    CCL256i2 (CL21256) is a 21.3-inch (54 cm) Color 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
    K112145
    Device Name
    MONOCHROME DIGITAL MAMMOGRAPHY LCD MONITOR MS33I2
    Manufacturer
    TOTOKU ELECTRIC CO., LTD
    Date Cleared
    2011-11-07

    (104 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
    20.8 inch Monochrome Digital Mammography 3M pixel LCD Monitor with sub-pixel driving techniques enabling 9M subpixels to be driven independently, MS33i2 (ML21033) 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
    MS33i2 (ML21033) is a 20.8-inch monochrome LCD monitor whose display resolution is 1536 x 2048 (landscape), 2048 x 1536 (portrait) supporting DVI (digital visual interface) and DisplayPort.
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    K Number
    K112604
    Device Name
    21.3 INCH (54 CM) COLOR LCD MONITOR CCL356I2 (CL21356)
    Manufacturer
    TOTOKU ELECTRIC CO., LTD
    Date Cleared
    2011-10-27

    (50 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) Color 3M pixel LCD Monitor CCL356i2 (CL21356) is intended 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
    CCL356i2 (CL21356) is a 21.3-inch (54 cm) Color LCD monitor whose display resolution is 1536 x 2048 (landscape), 2048 x 1536 (portrait) supporting DVI (digital visual interface) and Display Port.
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    K Number
    K111496
    Device Name
    21.3 INCH (54CM) MONOCHROME DIGITAL MAMMOGRAPHY LCD MONITOR
    Manufacturer
    TOTOKU ELECTRIC CO., LTD
    Date Cleared
    2011-09-26

    (118 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 5M pixel LCD Monitor with subpixel driving techniques enabling 15M subpixels to be driven independently, MS53i2 (ML21053) 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
    MS53i2 (ML21053) is a 21.3-inch (54 cm) monochrome LCD monitor whose display resolution is 2048 x 2560 (landscape), 2560 x 2048 (portrait) supporting DVI (digital visual interface).
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    K Number
    K092728
    Device Name
    20.1 INCH (51 CM) COLOR LCD MONITOR CCL208 (CDL2013A)
    Manufacturer
    TOTOKU ELECTRIC CO., LTD
    Date Cleared
    2010-11-19

    (441 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
    20.1-inch (51cm) Color LCD Monitor CCL208 (CDL2013A) is intended 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
    CCL208 (CDL2013A) is a 20.1-inch (51 cm) Color LCD monitor whose display resolution is 1200 x 1600 (landscape), 1600 x 1200 (portrait) supporting DVI (digital visual interface).
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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
    K081945
    Device Name
    21.3-INCH (54CM) MONOCHROME LCD MONITOR MS21I2 (MDL2127A)
    Manufacturer
    TOTOKU ELECTRIC CO., LTD
    Date Cleared
    2008-09-12

    (66 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 LCD Monitor with sub-pixel driving techniques enabling 6M subpixels to be driven independently, MS21i2 (MDL2127A) 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
    MS21i2 (MDL2127A) is a 21.3-inch (54 cm) Monochrome LCD monitor whose display resolution is 1200 x 4800 (landscape), 4800 x 1200 (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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