Acquisition and Clinical Image Evaluation of Fujifilm's High Resolution (HR) Digital Breast Tomosynthesis (DBT) Images.

Inclusion Criteria

• Have the ability to understand the requirements of the study, to provide written informed consent, and to comply with the study protocol;
• Have the ability to understand and provide written authorization for the use and disclosure of protected health information (PHI) per the Health Insurance Portability and Accountability Act (HIPAA) privacy ruling;
• Be female;
• Be at least 40 years of age;
• Be asymptomatic; and
• Have received a final BI-RADS Assessment Category of 1 or 2 (negative or benign findings) on her routine screening mammogram.

Exclusion Criteria

• Has a breast implant;
• Is pregnant or believes she may be pregnant;
• Has delivered and expressed the intention to breast-feed or is currently breast-feeding;
• Has significant existing breast trauma with the last one (1) year;
• Has any breast symptoms (e.g., breast lump, pain, nipple discharge);
• Has been diagnosed or treated for breast cancer within the last year; or
• Is an inmate (see US Code of Federal Regulations 45 CFR 46.306).