Acquisition of Mammography Images for Clinical Evaluation of FUJIFILM 3Dimensional Mammography
- Any ethnic or racial origin.
- Must come through the study via the screening or diagnostic pathway described above.
- Have the ability to understand the requirements of the study, to provide written
informed consent, and to comply with the study protocol.
- Meet none of the 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.
- Have self-reported severe non-focal or bilateral breast pain affecting subject's
ability to tolerate mammography examinations.
- A woman who has had a mammogram performed for the purpose of therapy portal
- Inadequate technical quality mammography images, such as insufficient anatomical
coverage or significant motion artifacts.
- Cannot, for any known reason, undergo follow-up mammography examinations (where
clinically indicated) at the participating institution.
- Is an inmate (see US Code of Federal Regulations 45CFR46.306).