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510(k) Data Aggregation

    K Number
    K152028
    Device Name
    Volpara Imaging Software
    Manufacturer
    MATAKINA TECHNOLOGIES LIMITED
    Date Cleared
    2015-10-26

    (96 days)

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

    MATAKINA TECHNOLOGIES LIMITED

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Volpara is a software application intended for use with the raw data from digital breast x-ray systems, including tomosynthesis. Volpara calculates a density map and from that determines volumetric breast density as a ratio of fibroglandular tissue and total breast volume estimates. Volpara provides these numerical values along with a BI-RADS breast density 4th or 5th Edition category to aid health care professionals in the assessment of breast tissue composition. Volpara produces adjunctive information. It is not an interpretive or diagnostic aid.
    Device Description
    The Volbara 1.5.1 software provides volumetric assessment of digital x-ray images of the breast, including in that definition both digital mammograms and raw tomosynthesis projections. The assessments takes the form of generating and validating density maps where the value at each pixel represents the thickness of fibroglandular tissue between that pixel and the x-ray source. From those density maps various quantitative densitymap based statistics are computed, for example, volume of fibroglandular tissue in cm³, volume of breast in cm3, and their ratio, the volumetric breast density, along with a Bl-RADS 4th Edition, 5th Edition breast density category by simple thresholding of the volumetric breast density. Volpara operates on a Windows server that meets Volpara data input and output requirements and generally is located outside the patient environment. The device does not contact the patient, nor does it control any life-sustaining devices.
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