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 -

Exclusion Criteria:

1. Subject is pregnant or possibly pregnant or planning pregnancy within the next 15
months

2. Subject has undergone a breast augmentation or breast implant? Has subject had any of
the following breast procedures?

Fine needle or cyst aspiration NOT Eligible if within past year Biopsy Not Eligible
if within past year Lumpectomy (for breast cancer) Mastectomy (for breast cancer)
Radiation therapy Breast reconstruction Breast reduction Not Eligible if within
past year

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