Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Fujifilm Medical Systems USA, Inc.
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.
Age
18–any
Sex
FEMALE
Healthy volunteers
Accepted
You may be eligible if
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
You may not be if
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).
