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510(k) Data Aggregation

    K Number
    K102556
    Device Name
    VOLPARA, VERSION 1.3
    Manufacturer
    MATAKINA TECHNOLOGY LIMITED
    Date Cleared
    2010-10-07

    (30 days)

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

    MATAKINA TECHNOLOGY LIMITED

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Volpara is a software application intended for use with digital mammography systems. Volpara calculates volumetric breast density as a ratio of fibroglandular tissue and total breast volume estimates. Volpara provides these numerical values for each image to aid radiologists in the assessment of breast tissue composition. Volpara produces adjunctive information. It is not an interpretive or diagnostic aid. Volpara is a software application which runs on Windows or Linux based computers.
    Device Description
    Volpara™ analyzes raw ("for processing") digital mammograms in a fully automated, volumetric fashion and produces a quantitative assessment of breast composition, namely volume of fibroglandular tissue in cubic centimeters (cm³) volume of breast tissue in cm³ and their ratio, volumetric breast density. Volpara v1.3 handles DICOM files as input. Volpara v1.3has been built and tested on Windows XP and Linux. Volpara software is a component which accepts as input digital mammography images along with associated calibration data. The software processes the image according to proprietary algorithms. It provides measures of: volume of fibroglandular tissue, volume of breast, breast density. The software does not perform image display but outputs to the console.
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