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.