Acquisition of Breast Mammography Images

Acquisition of Digital Mammography and Breast Images for Clinical Evaluation of FujifilmDigital Breast Tomosynthesis

This is a case collection study of breast images using standard and new mammography technology.

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).