Radiological Devices Panel of the Medical Devices Advisory Committee

Radiological Devices Panel of the Medical Devices Advisory Committee
Committee Meeting April 11, 2012 from 8:00 a.m. – 6:00 p.m. (Day 1 of 2)

Agenda: On April 11, 2012, the committee will discuss, make recommendations, and vote on information related to a premarket approval application for the Automated Breast Ultrasound (ABUS) scanning device, sponsored by U-Systems, Inc. The ABUS scanning device is intended to increase breast cancer detection in asymptomatic dense-breasted women following a negative screening mammogram.