The study will be performed in two phases: Image Accrual and Image Reading.~Approximately 800 women who fulfill all inclusion and exclusion criteria will be enrolled in chronological order from up to 3 different US sites with one study investigator for each site. Two cohorts of patients will be enrolled (i.e., Biopsy and Screening Cohorts). Paired sets of a standard 4-view exam will be collected both from Philips Tomosynthesis system (Tomosynthesis and synthetic 2D images) and a FDA-cleared FFDM system. All enrolled cases will be quality controlled for completeness of image and patient information.~The reading portion of the study will include approximately 300 normal cases (including some cases determined to be normal after call back after screening mammography), 65 cancer cases, and 40 biopsy proven benign cases.~The primary objective of the study is to compare the safety and clinical performance of the Philips MicroDose Tomosynthesis system (Tomosynthesis and synthetic 2D) images to conventional 2D mammography images (FFDM).
The primary objective of this study is to compare the safety and clinical performance of the Philips MicroDose Tomosynthesis system images and images from FFDM systems.