Search Results

General Indication for Use: An ultrasound pulsed echo imaging system is intended to project a pulsed sound beam into body tissue to determine the depth of location of the tissue interfaces and to measure the duration of an acoustic pulse from the transmitter to the tissue interface and back to the receiver. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts and accessories. Specific Indications for Use: The device is indicated for use as an adjunct to mammography for B-mode ultrasonic imaging of a patient's breast when used with an automatic scanning linear array transducer or a handheld transducer. The device is not intended to be used as a replacement for screening mammography.

The ABUS system with automated ultrasound imaging of the breast, gives the radiologist a cost-effective solution for reviewing the ultrasound images with the corresponding mammogram. The modification to the sponsor's predicate device consists of the addition of the accessory of a conventional handheld ultrasound transducer, and modification to the software to control the new transducer.