FDA 483 - Imagen Technologies Inc. - January 25, 2024

Imagen Technologies Inc., a manufacturer of Class II AI software including Chest CAD and Fracture Detect, was inspected by the FDA. The inspection revealed significant deficiencies in the firm's complaint handling procedures. Specifically, the company failed to adequately establish procedures for receiving, reviewing, and evaluating complaints, resulting in numerous complaint files lacking essential data for proper investigation and trending of issues.