Device typeBreast ultrasound imaging system: An assembly of electrically-powered devices designed for extracorporeal and/or intracorporeal (endosonography or endoscopic) ultrasound imaging procedures involving the breast. It typically includes special imaging tables used to optimize the ability to give reproducible images of the breast. It typically includes software packages that support a variety of static or real-time breast specific imaging used primarily for oncology. It will generate ultrasound pulses, direct them to the target area, detect the ultrasound echoes, and process the resulting information to produce and display static or dynamic two- or three-dimensional (3-D) images.
FDA categoryAutomated Breast Ultrasound
Device ID00860000221306
Catalog number900-00035
AvailabilityPrescription
MRI safetyLabeling does not contain MRI Safety Information