RADIOLOGICAL DEVICES PANEL

March 5, 2001

Briefing Information

Purpose of the Meeting - To discuss, make recommendations and vote on a premarket approval application (PMA P000041) for a computer-aided detection (CAD) device for identifying regions of interest in chest radiographs.

ROC Overview - Robert F Wagner, PhD   pdf

Summary and Effectiveness Data for RapidScreen RS-2000, Deus Technologies   pdf

PMA Overview, Robert J Doyle   pdf

Clinical Presentation, William Sacks, PhD, MD   pdf

Statistical Presentation, Marina Kondratovich, PhD   pdf