Food and Drug Administration

Medical Devices Advisory Committee

Radiological Devices Panel

February 3, 2004

Briefing Information

Table of Contents (HTM) (PDF) (Word)

December 16, 2003 Memorandum Regarding ImageChecker, CT CAD Software System, CAD For Lung Nodules on Chest CT Scans (HTM) (PDF) (Word)

ImageChecker CT CAD Software System - Clinical Discription Part 1, Dr. William Sacks, PhD, MD, FDA (PPT)

Corrected Version of the Description, Dr. William Sacks, PhD, MD, FDA (PPT)

Corrected Version of the Conclusions, Dr. William Sacks, PhD, MD, FDA (PPT)

R2 ImageChecker CT CAD PMA: Clinical Results, Dr. Nicholas Petrick, PhD, FDA (PPT)

Summary of Safety and Effectiveness Data (HTM) (PDF) (Word)

Panel Discussion Points (HTM) (PDF) (Word)