50162975-7681-430f-8b76-e01ba563d5c8UpdatePublished42024-08-162017-03-302017-03-31Not in Commercial Distribution15420045505995PrimaryGS1Selenia FFDMASY-06715ASY-06715139534114Hologic, Inc.1falsefalsefalsefalsefalsefalsefalsetruetruefalsefalsefalsefalseLabeling does not contain MRI Safety InformationtruefalseP01002501237672Stationary mammographic x-ray system, digitalA stationary assembly of devices designed to generate x-ray images of the breast using digital techniques for image capture and display. It is designed specifically to compress the breast during imaging and is intended to visually evaluate the anatomy and function of blood and lymphatic vessels within the breast. Often referred to as a digital mammography system (DMS) it is typically used for breast cancer screening or during biopsy procedures (e.g., placement of biopsy markers, stereotactic biopsy). It is designed to capture two-dimensional (2-D) x-ray images, however may include software intended to process multiple images to create a three-dimensional (3-D) image/model (tomosynthesis).falseActiveMUEFull field digital,system,x-ray,mammographicfalsefalse