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510(k) Data Aggregation

    K Number
    K101796
    Device Name
    PACSMATE MMD-5201M MONITOR
    Date Cleared
    2010-07-15

    (17 days)

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

    IEI TECHNOLOGY CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The device is intended to be used as a tool in displaying and viewing digital images, including digital mammography system for view and analyses by trained medical practitioner.
    Device Description
    The MMD-5201M LCD monitors are displays for medical use. MMD-5210M provides 5 mega pixel resolution and 766 grayscales per pixel display. The display device is complied with the standard ISO13406-2 to conform to the requirement of the mammography display system.
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    K Number
    K091687
    Device Name
    PACSMATE, MODEL MMD-4300C/MMD-4300CX
    Date Cleared
    2009-07-07

    (27 days)

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

    IEI TECHNOLOGY CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    PACSmate MMD=4300C/4300CX is intended to be used in displaying and viewing digital images for diagnosis of X-ray or MRI, etc. by trained medical practitioners. PACSmate MMD-4300C/4300CX does not support the display of mammography images for diagnosis.
    Device Description
    The PACSmate MMD-4300C/4300CX is a 30" monochrome/color LCD display for medical image viewing.4 Mega pixel medical grade LCD monitor with high resolutions.
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    K Number
    K082496
    Device Name
    PACSMATE MMD-3213M MONITOR
    Date Cleared
    2008-09-09

    (11 days)

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

    IEI TECHNOLOGY CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The device is intended to be used to as a tool in displaying and viewing digital images view and analyses by trained medical practitioner. The device is not specified for digital mammography system.
    Device Description
    The MMD-3213M LCD monitors are displays for medical image viewing. MMD-3213M provides 3 mega pixel resolution. The PACSmate MMD-3213M is a high performance, 3 Megapixel medical grade monochrome LCD monitors designed for exacting needs for diagnostics professionals that provide clear and sharp images with resolutions of up to 2048 x 1536 pixels, 600 cd/m2 brightness and 700:1 contrast ratio, making it ideal for diagnosing detailed medical graphics. Also uses a DVI digital interface offering compatibility with the latest digital standards.
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