Study to Compare the Diagnostic Accuracy of Nuance Full-Field Digital Mammography to Screen-Film Mammography

Inclusion Criteria

• •1. Subject is 40 years of age or older
• •2. Subject is presenting for routine breasts cancer screening (Cohort I) OR Subject has one or both breasts scored 4 or 5 on the BI-RADS scale as a result of SFM either for routine breast cancer screening or for follow-up or diagnostic mammography (Cohort II)
• •3. Subject's schedule permits the SFM and the FFDM to be performed no more than 30 days apart and with no intervention between the exams
• •4. Subject will provide prospective, written informed consent
• •5. Subject is considered capable of complying with study procedures including a willingness to return for a one-year follow-up exam -
• •3. Subject has had an invasive breast procedure or operation within the past year
• •4. Subject has significant existing breast trauma
• •5. Subject has a history of breast cancer treated with operation or radiation
• •6. Subject has any other condition or personal circumstance that, in the judgment of the investigator, might interfere with the collection of complete good quality data