Automated Breast Ultrasound and Digital Breast Tomosynthesis Screening Compared to Full Field Digital Mammography in Women With Dense Breasts

Inclusion Criteria: * Able and willing to provide signed declaration of informed consent or have a legally authorized representative provide signed declaration of informed consent for participation in all study procedures; * Women aged ≥18 years at the time of enrollment;\* * Women with a previous determination of dense breasts determined by mammogram as heterogeneously dense or extremely dense; * At moderately increased or high risk (\>15% lifetime risk) for breast cancer based on meeting one or more of the ACS criteria 1: AND Referred for screening mammography Exclusion Criteria: * Have been screened using any breast imaging technology in \<12 months immediately prior to enrollment; * Exhibit breast cancer symptoms according to assessment by the subject's health care provider within one year prior to enrollment; * Diagnosed with breast cancer, with or without metastasis, within one year prior to enrollment; * Are currently pregnant as determined per standard clinical practice at the investigational site; * Present with contraindications to any imaging examination required in the study protocol; * Have breast implants; OR * Are lactating.