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510(k) Data Aggregation

    K Number
    K061303
    Device Name
    MEDICAL DISPLAY, MODELS MDM 1900-1NG AND MDM 1900-1NR
    Manufacturer
    CHILIN TECHNOLOGY CO. LTD
    Date Cleared
    2006-05-25

    (15 days)

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

    CHILIN TECHNOLOGY CO. LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    1.3MP Medical Monochrome Reference Display, MDM1900-1NG MDM1900-1NR 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, MDM1900-1NG is a 19" monochrome LCD monitor that displays image for medical use. It provides 1.3 mega pixel (1280 x 1024/1024 x 1280) 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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    K Number
    K061305
    Device Name
    MEDICAL DISPLAY, MDC1900-1LG (1LR)
    Manufacturer
    CHILIN TECHNOLOGY CO. LTD
    Date Cleared
    2006-05-25

    (15 days)

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

    CHILIN TECHNOLOGY CO. LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    1.3MP Medical Color Reference Display, MDC1900-1LG (ILR) 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
    1.3MP Medical Color Reference Display, MDC1900-1LG (ILR) is a 19" color LCD monitor that displays image for medical use. It provides 1.3 mega pixel (1280 x 1024/1024 x 1280) resolution and enable the user to define desired DICOM GSDF Gamma settings such as 1.8, 2.0, 2.2 and 2.4 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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