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510(k) Data Aggregation

    K Number
    K073358
    Device Name
    LUMIMED SERIES 5MP DIGITAL FLAT PANEL DISPLAY SYSTEM, MODEL MM50/MM50A
    Manufacturer
    Date Cleared
    2008-04-25

    (148 days)

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

    HEEYOUNG CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Lumimed Series 5MP Digital Flat Panel Display System ™ is intended to be used in displaying and viewing digital medical images for review and analysis by trained medical practitioners. It is specifically designed for digital mammography applications.
    Device Description
    Lumimed Series 5MP Digital Flat Panel Display System™ is a flat panel hiresolution LCD monitor system for displaying medical images. The system consists of a state-of-the-art LCD monitor and a high-resolution graphic control board that connects to a PACS workstation for grayscale and color image display. The controller board is installed into the PACS workstation computer or other computer system used to display PACS medical images.
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    K Number
    K073292
    Device Name
    MM/MMA/COLOR SERIES DIGITAL FLAT PANEL DISPLAY SYSTEM
    Manufacturer
    Date Cleared
    2008-01-18

    (56 days)

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

    HEEYOUNG CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The MM/MMA/Color Series Digital Flat Panel Display System™ is intended to be used in displaying and viewing digital medical images for review and analysis by trained medical practitioners. This device must not be used for primary image diagnosis in mammography
    Device Description
    The MM/MMA/Color Series Digital Flat Panel Display System™ is a flat panel hiresolution LCD monitor system for displaying medical images. The system consists of a state-of-the-art LCD monitor and a high-resolution graphic control board that connects to a PACS workstation for grayscale and color image display. The controller board is installed into the PACS workstation computer or other computer system used to display PACS medical images.
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    K Number
    K052120
    Device Name
    LUMIMED MONOCHROME LCD MONITOR, MODELS MM 20, MM 30 AND MM50
    Manufacturer
    Date Cleared
    2005-12-16

    (134 days)

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

    HEEYOUNG CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Monochrome LCD Monitors intended to be used in various kinds of medical image applications (excluding digital mammography) for which the device complies with the performance specified by the manufacturer of the system.
    Device Description
    Monochrome LCD Monitors (MM 20, MM 30 and MM 50) are used to display images such as X-ray, or MRI images. These models have resolutions of: 2560 X 2048, 2048 X 1536 and 1600 X 1200. These models have USB functions and an optional photo sensor GFU12-SEQ01 made by Gretagmacbeth. These models are certified to the EN 60601-1 medical safety standard. The monitors use universal switching power supplies compatible with AC100V-120V/200V-240V ,50/60Hz. The graphics card needed for the personal computer is the VREngine MD/SMD Series. The monitors may be deployed in the portrait or the landscape position.
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