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510(k) Data Aggregation

    K Number
    K063269
    Device Name
    5MP MEDICAL MONOCHROME REFERENCE DISPLAY, MODEL MDM2010-5NC
    Manufacturer
    CHI LIN TECHNOLOGY CO., LTD.
    Date Cleared
    2007-05-23

    (205 days)

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

    CHI LIN TECHNOLOGY CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    5 MP Medical Monochrome Reference Display, MDM2010-5NC is intended to be used in various kinds of medical images applications including digital mammography system.
    Device Description
    Medical Display, MDM2010-5NC 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, PACS and digital mammography system.
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    K Number
    K063579
    Device Name
    2MP MEDICAL COLOR REFERENCE DISPLAY, MODEL MDC2130-2HC
    Manufacturer
    CHI LIN TECHNOLOGY CO., LTD.
    Date Cleared
    2006-12-14

    (14 days)

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

    CHI LIN TECHNOLOGY CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    2MP Medical Color Reference Display, MDC2130-2HC is intended to use in displaying images for review and analysis by trained medical practitioner for diagnose in CT, MRI, HIS and PACS. This device is not suitable for a digital mammography system.
    Device Description
    Medical Display, MDC2130-2HC is a 21.3" color LCD monitor that displays image for medical use. It provides 2 mega pixel (1600 x 1200) resolution and enable the user to define desired DICOM GSDF Gamma settings such as 1.8, 2.0 and 2.2 for more precise diagnose use in CT, MRI, HIS and PACS. This device is not suitable for a digital mammography system.
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    K Number
    K063289
    Device Name
    2MP MEDICAL MONOCHROME REFERENCE DISPLAY, MODEL MDM2130-2NC
    Manufacturer
    CHI LIN TECHNOLOGY CO., LTD.
    Date Cleared
    2006-11-16

    (15 days)

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

    CHI LIN TECHNOLOGY CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    2MP Medical Monochrome Reference Display, MDM2130-2NC is intended to use in displaying images for review and analysis by trained medical practitioner for diagnose in CT, MRI, HIS and PACS. This device is not suitable for a digital mammography system.
    Device Description
    2MP Medical Monochrome Reference Display - MDM2130-2NC.
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    K Number
    K063266
    Device Name
    3MP MEDICAL MONOCHROME REFERENCE DISPLAY, MODEL MDM2130-3NC
    Manufacturer
    CHI LIN TECHNOLOGY CO., LTD.
    Date Cleared
    2006-11-09

    (10 days)

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

    CHI LIN TECHNOLOGY CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    3MP Mcdical Monochrome Reference Display, MDM2130-3NC is intended to use in displaying images for review and analysis by trained medical practitioner for diagnose in CT, MRI, HIS and PACS. This device is not suitable for a digital mammography system.
    Device Description
    Medical Display, MDM2130-3NC 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. This device is not suitable for a digital mammography system.
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