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Volpara Imaging Software is a software application intended for use with the raw data from digital breast x-ray systems, including tomosynthesis. Volpara Imaging Software 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 Imaging Software provides these numerical values along with a BI-RADS breast density 4th or 5th Edition category and quality assurance metrics (i.e., dose and pressure) to aid healthcare professionals in the assessment of breast composition. Volpara Imaging Software is not a 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.

Volpara Imaging Software 3.2 analyzes raw ("For Processing") digital mammograms or raw DBT projections in a fully automated, volumetric fashion. It produces a quantitative assessment of breast composition in the form of a Volpara density map, wherein the value at each pixel represents the thickness of fibroglandular tissue between that pixel and the x-ray source. From the density maps various quantitative density-map based metrics are computed as follows: - volume of fibroglandular tissue in cm3 - volume of breast in cm³ - the volumetric breast density (the percentage of fibroglandular tissue in breast) - average thickness of dense tissue in cm - maximum thickness of dense tissue in cm - maximum volume of dense tissue above any 1 cm² square region (and location) - image quality assessment metrics Volpara Imaging Software typically receives four standard views from the digital x-ray system following a mammographic or digital breast tomosynthesis screening examination (i.e., left CC, right CC, left MLO, right MLO). The generated results are then displayed via either of the following: - A Volpara scorecard (a DICOM Secondary Capture Image) - A DICOM Mammography CAD Structured Report The device outputs those metrics along with the density maps themselves marked with the location of the various maxima. Using the volumetric breast density, a Bl-RADS 4th Edition and 5th Edition breast density category is generated by applying thresholds set by the software. Volpara Imaging Software operates on a Microsoft Azure-connected, off-the-shelf virtual appliance, which provides a secure, pre-configured virtual host. Volpara Imaging Software does not contact the patient, nor does it control any life-sustaining devices.

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 Imaging Software ("Volpara") 1.5.6 software provides volumetric assessment of digital x-ray images of the breast, including in that definition both raw digital mammograms and raw tomosynthesis projections (the central projections of which are just raw digital mammograms). The assessment takes the form of generating and validating density maps wherein the value at each pixel represents the thickness of fibroglandular tissue between that pixel and the x-ray source. From the density maps various quantitative density-map based statistics are computed as follows: - . volume of fibroglandular tissue in cm³ - volume of breast in cm3, . - the volumetric breast density (the percentage of fibroglandular tissue in breast) . - average thickness of dense tissue in cm . - maximum thickness of dense tissue in cm . - maximum volume of dense tissue above any 1cm² square region (or "focal ● density") From the volumetric breast density, a BI-RADS 4th Edition and 5th Edition breast density category can be attained by applying thresholds set by the software. The device outputs those metrics along with the density maps themselves marked with the location of the various maxima. Volpara Imaging Software 1.5.2 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.