Acquisition of Breast Mammography Images

This image acquisition study is designed to acquire the study image data and establish and
document the clinical findings for each subject. This study will create a library of image
data that will be used for future projects.

Inclusion Criteria:

For Screening Subjects

- Be at least 40 years of age, are

- Asymptomatic,

- Scheduled for a routine screening mammogram

For Recall Subjects

- Be at least 18 years of age,

- Received a BIRADS 0 within the last 60 days

- Are recalled for additional imaging

For Diagnostic Subjects

- Be at least 18 years of age,

- Scheduled for a biopsy due to an assessment of Breast Imaging and Reporting Data
(BI-RADS®) 4 or 5 after diagnostic work-up of a suspicious screening or clinical
finding within the last 60 days.

- Understand requirements and willing to participate in study

Exclusion Criteria:

- Presence of a breast implant.

- Women with only a single breast; for example, post mastectomy patients.

- Is pregnant or believes she may be pregnant.

- A woman who has delivered and who has expressed the intention to breast-feed or is
currently breast-feeding.

- A woman who has significant existing breast trauma within the last one year.

- Have self-reported severe non-focal or bilateral breast pain affecting subject's
ability to tolerate digital mammography and/or breast tomosynthesis examinations.

- A woman who has had a mammogram performed for the purpose of therapy portal planning
within the last year.

- Cannot, for any known reason, undergo follow-up digital mammography and/or breast
tomosynthesis examinations (where clinically indicated) at the participating
institution.

- Is an inmate (see US Code of Federal Regulations 45CFR46.306).