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The device is indicated for use as a B-mode ultrasonic imaging of a patient's breast when used with an automatic scanning linear array transducer. The device is not intended to be used as a replacement for screening mammography. Operator: Trained Healthcare Professional Patient Population: Ages 18 and above Environment of use: Facilities where healthcare is provided - e.g. hospitals, clinics, physician offices, mobile care units.

The ATUSA™ Automated 3D Breast Ultrasound System is a battery operated Track 3 diagnostic ultrasound system intended for imaging of the breast. The device utilizes B-mode grayscale ultrasound via an automated linear transducer and consists of the following components: - 1) Automated ultrasound scanner that integrates all hardware components including the transducer, electronics, and mechanical parts in a compact form factor. The scanner connects to a laptop via USB cable and automatically captures ultrasound images of the breast volume; - 2) Positioning accessory that includes a pair of expandable cups, disposable straps, drain bags and mesh. The expandable cups are assembled as a wearable accessory with disposable straps to form the breast tissue conveniently in the field of view of the scanner and facilitate reproducible positioning of the scanner on the breast. The expandable cups come in different sizes to accommodate a range of breast sizes; - 3) Charger base for wirelessly charging the scanner battery; - 4) Software application to control the scanner operation, to acquire and display the images in realtime, and to perform advanced image processing, 3D reconstruction and visualization in various image planes.