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510(k) Data Aggregation

    K Number
    K133708
    Device Name
    MD302C4 29.8 DIAGNOSTIC IMAGING LCD MONITOR
    Date Cleared
    2014-02-14

    (72 days)

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

    NEC DISPLAY SOLUTIONS, LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The MD302C4 color display is intended to be used for displaying and viewing of digital images for diagnosis by trained physicians. To guarantee the display performance as specified, it must only be used for in conjunction with NEC approved display controllers. MD302C4 cannot be used for a life-support system. This device must not be used in digital mammography. This device is designed for exclusive interconnection with IEC60601-1-1 certified equipment.
    Device Description
    Medical Display, MD302C4 is a 29.8" Color LCD monitor that displays image for medical use. It provides 4 mega pixel (2560*1600) resolution with adjustable gamma gray scale for more precise diagnose use in CT, MRI, HIS, and PACS.
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    K Number
    K130770
    Device Name
    MD211C3 21.3 DIAGNOSTIC IMAGING LCD MONITOR
    Date Cleared
    2013-04-18

    (29 days)

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

    NEC DISPLAY SOLUTIONS, LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The MD211C3 color display is intended to be used for displaying and viewing of digital images for diagnosis by trained physicians. To guarantee the display performance as specified, it must only be used in conjunction with NEC approved display controllers. MD211C3 cannot be used for a life-support system. This device must not be used in digital mammography. This device is designed for exclusive interconnection with IEC60601-1-1 certified equipment.
    Device Description
    Medical Display, MD211C3 is a 21.3" Color LCD monitor that displays image for medical use, It provides 3 mega pixel (2048*1536) resolution with adjustable gamma gray scale for more precise diagnose use in CT, MRI, HIS, and PACS.
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    K Number
    K130772
    Device Name
    MD211C2 21.3 DIAGNOSTIC IMAGING LCD MONITOR
    Date Cleared
    2013-04-18

    (29 days)

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

    NEC DISPLAY SOLUTIONS, LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The MD211C2 color display is intended to be used for displaying and viewing of digital images for diagnosis by trained physicians. To guarantee the display performance as specified, it must only be used for in conjunction with NEC approved display controllers. MD211C2 cannot be used for a life-support system. This device must not be used in digital mammography. This device is designed for exclusive interconnection with IEC60601-1-1 certified equipment.
    Device Description
    Medical Display, MD211C2 is a 21.3" Color LCD monitor that displays image for medical use. It provides 1.9 mega pixel (1600*1200) resolution with adjustable gamma gray scale for more precise diagnose use in CT, MRI, HIS, and PACS.
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    K Number
    K111237
    Device Name
    MD301C4 29.8 DIAGNOSTIC IMAGING LCD MONITOR, L309TY
    Date Cleared
    2011-06-15

    (44 days)

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

    NEC DISPLAY SOLUTIONS, LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    MD301C4 is intended to be used for displaying and viewing of digital images for diagnosis by trained physicians. Caution: MD301C4 cannot be used for a life-support system. This unit is designed as component of a final system which is compliance to IEC60601-1-1 requirements. MD301C4 must not be used in digital mammography.
    Device Description
    Medical Display, MD301C4 is a 29.8" Color LCD monitor that displays image for medical use. It provides 4 mega pixel (2560*1600) resolution with adjustable gamma gray scale for more precise diagnose use in CT, MRI, HIS, and PACS. MD301C4 conforms with DICOM.
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    K Number
    K090215
    Device Name
    MD213MG 21.3 DIAGNOSTIC IMAGING LCD MONITOR - L218TL
    Date Cleared
    2009-04-15

    (76 days)

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

    NEC DISPLAY SOLUTIONS, LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The L218TL Monochrome display is intended to be used for displaying and viewing of digital image diagnosis by trained physicians. To guarantee the display performance as specified, it must only be used for in conjunction with NEC approved display cards. The L218TL cannot be used for a life-support system. This device must not be used in digital mammography. This unit is designed for exclusive interconnection with IEC60601-1 certified equipment.
    Device Description
    Medical Display, L218TL is a 21.3" Monochrome LCD monitor that displays image for medical use. It provides 3 mega pixel (2048*1536) resolution with adjustable gamma gray scale for more precise diagnose use in CT, MRI, HIS, and PACS.
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    K Number
    K090218
    Device Name
    MD213MC 21.3 DIAGNOSTIC IMAGING LCD MONITOR MODEL, L218TJ
    Date Cleared
    2009-04-15

    (76 days)

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

    NEC DISPLAY SOLUTIONS, LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The L218TJ Color display is intended to be used for displaying and viewing of digital image diagnosis by trained physicians. To guarantee the display performance as specified, it must only be used for in Conjunction with NEC approved display cards. The L218TJ cannot be used for a life-support system. This device must not be used in digital mammography. This unit is designed for exclusive interconnection with IEC60601-1 certified equipment.
    Device Description
    Medical Display, L218TJ is a 21.3" Color LCD monitor that displays image for medical use. It provides 3 mega pixel (2048*156) resolution with adjustable gamma gray scale for more precise diagnose use in CT, MRI, HIS, and PACS.
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    K Number
    K083916
    Device Name
    LCD3090WQXI OR MD304MC 29.8 INCH DIAGNOSTIC IMAGING LCD MONITOR, MODEL L307TD
    Date Cleared
    2009-01-14

    (15 days)

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

    NEC DISPLAY SOLUTIONS, LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The L307TD Color display is intended to be used for displaying and viewing of digital image diagnosis by trained physicians. To guarantee the display performance as specified, it must only be used for in Conjunction with NEC approved display cards. TheL307TD cannot be used for a life-support system. This device must not be used in digital mammography. This unit is designed for exclusive interconnection with IEC60601-1 certified equipment.
    Device Description
    Medical Display, L307TD is a 29.8" Color LCD monitor that displays image for medical use. It provides 4 mega pixel (2560*1600) resolution with adjustable gamma gray scale for more precise diagnose use in CT, MRI, HIS, and PACS.
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    K Number
    K083907
    Device Name
    MD212MC 21.3 DIAGNOSTIC IMAGING LCD MONITOR-L217TG
    Date Cleared
    2009-01-13

    (14 days)

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

    NEC DISPLAY SOLUTIONS, LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The L217TG Color display is intended to be used for displaying and viewing of digital image diagnosis by trained physicians. To guarantee the display performance as specified, it must only be used for in Conjunction with NEC approved display cards. The L217TG cannot be used for a life-support system. This device must not be used in digital mammography. This unit is designed for exclusive interconnection with IEC60601-1 certified equipment.
    Device Description
    Medical Display, L217TG is a 21.3" Color LCD monitor that displays image for medical use. I It provides 2 mega pixel (1600*1200) resolution with adjustable gamma gray scale for more precise diagnose use in CT, MRI, HIS, and PACS.
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    K Number
    K083332
    Device Name
    MD21M 21.3 DIAGNOSTIC IMAGING LCD MONITOR, MODEL L218TK
    Date Cleared
    2009-01-09

    (58 days)

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

    NEC DISPLAY SOLUTIONS, LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The L218TK Color display is intended to be used for displaying and viewing of digital image diagnosis by trained physicians. To guarantee the display performance as specified, it must only be used for in Conjunction with NEC approved display cards. TheL218TK cannot be used for a life-support system. This unit is designed for exclusive interconnection with IEC60601 -1 certified equipment.
    Device Description
    Medical Display, L218TK is a 21.3" Color LCD monitor that displays image for medical use. It provides 2 mega pixel (1600*1200) resolution with adjustable gamma gray scale for more precise diagnose use in CT, MRI, HIS, and PACS.
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    K Number
    K082493
    Device Name
    MEDICAL DISPLAY, MD205MG-1
    Date Cleared
    2008-10-23

    (55 days)

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

    NEC DISPLAY SOLUTIONS, LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The MD205MG-1 grayscale display is intended to be used for displaying and viewing of digital image diagnosis including digital mammography by trained physicians. To guarantee the display performance as specified, it must only be used for in Conjunction with NEC approved display cards. The MD205MG-1 cannot be used for a life-support system. This unit is designed for exclusive interconnection with IEC60601-1 certified equipment.
    Device Description
    Medical Display, MD205MG-1 is a 20.1" monochrome LCD monitor that displays image for medical use. It provides 5 mega pixel (2560*2048) resolution with adjustable gamma gray scale for more precise diagnose use in CT, MRI, HIS, and PACS.
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