Device typeStationary mammographic x-ray system, digital: A 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).
FDA categoryDigital breast tomosynthesis
Device ID15420045512313
Catalog numberSW-05673
AvailabilityPrescription
MRI safetyLabeling does not contain MRI Safety Information