Inclusion Criteria:

- Women ≥18 years or older and has underwent screening mammography and is now referred
for diagnostic mammography

- Able and willing to comply with study procedures, and have signed and dated the
informed consent form

- Surgically sterile or postmenopausal

Exclusion Criteria:

- Pregnant or trying to become pregnant

- Has signs or symptoms of breast cancer

- Has been previously included in this study

- Has breast implants

- Has a history of breast cancer and is in active treatment

- Has breasts too large to be adequately positioned for the DBT examination