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510(k) Data Aggregation

    K Number
    K160347
    Device Name
    Hisense LDC monitor models HMD2G21/HMD3G21/HMD5G21
    Date Cleared
    2016-03-03

    (24 days)

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

    QINGDAO HISENSE MEDICAL EQUIPMENT CO.,LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The 2MP/3MP LCD Monitor (HMD2G21) is intended to be used in displaying and viewing digital images (excluding digital mammography) for review and analysis by trained medical practitioners. The 5MP LCD Monitor (HMD5G21) is intended to be used in displaying digital images for review and analysis by trained medical practitioners, including digital mammography.
    Device Description
    The 2MP/3MP/5MP LCD Monitor (HMD2G21/HMD3G21) is a display system for medical viewing, with high resolution 1600x1200(HMD2G21)/2048 x 1536(HMD3G21)/ 2560 x 2048(HMD5G21), built-in brightness stabilization circuit, front sensor and ambient light sensor, stable brightness and persistent calibration can be guaranteed. The display can support both landscape and portrait mode. The antiglare screen can prevent display from reflection under highlight conditions, make the image and display clearer.
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