This image-acquisition study is designed to acquire the study image data and establish and document the clinical findings for each subject. The acquired data will be used to support FUJIFILM protocol FMSU2011-003B (Clinical Evaluation of FUJIFILM 3Dimensional Digital Mammography) and future regulatory submissions.
This is an image acquisition reader study to observe differences between 3D FujiFilm Mammography and 2D approved Mammography
Study Type
OBSERVATIONAL
Enrollment
600
The FUJIFILM 3DM examination is a 4-view mammogram which includes CC and MLO views of each breast. For each view, a routine (0-degree) mammogram will be acquired followed immediately in the same compression by a second mammogram offset at 4 degrees.
Standard of care screening mammogram.
Scottsdale Medical Imaging, Limited (SMIL)
Scottsdale, Arizona, United States
Emory University Healthcare
Atlanta, Georgia, United States
Elizabeth Wende Breast Care, LLC (EWBC)
Rochester, New York, United States
Acquire screening cases with and without breast cancer.
Time frame: 18-months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.