Date Published:
Tue, 07/03/2012In July 2012, the US FDA published this guidance for industry and FDA staff, Computer-Assisted Detection Devices Applied to Radiology Images and Radiology Device Data - Premarket Notification [510(k)] Submissions.
This document provides recommendations regarding premarket notification 510(k) submissions for computer assisted detection (CADe) devices applied to radiology images and radiological device data.
CADe devices are computerized systems that incorporate pattern recognition and data analysis capabilities and are intended to identify, mark, highlight, or direct attention to portions of an image, or aspects of radiological data to reveal abnormalities during interpretation of patient data.