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Volpara is a software application intended for use with the raw data from digital breast x-ray systems, including tomosynthesis. Volpara calculates and quantifies 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 is not an interpretive or diagnostic aid and should be used only as adjunctive information when the final assessment of breast density category is made by an MQSA qualified interpreting physician.

The Volpara 1.5.2 software provides volumetric assessment of digital x-ray images of the breast, including in that definition both digital mammograms and raw tomosynthesis projections. The assessment 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, namely: - volume of fibroglandular tissue in cm3, ● - volume of breast in cm3 ● - the volumetric breast density in %, - a BI-RADS 4th Edition or 5th Edition breast density category ● - average thickness of dense tissue - maximum thickness of dense tissue - maximum volume of dense tissue above any 1cm² square region ● The device outputs those numbers along with the density maps themselves marked with the location of the various maxima. 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.