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R2 panel review

This article was originally published in The Gray Sheet

Executive Summary

Lung nodule detection claim for ImageChecker CT LN-1000 computer assisted detection system will be reviewed by FDA's Radiology Devices Panel Feb. 3 (1"The Gray Sheet" Dec. 15, 2003, p. 15). The indication will be supported by 18-month clinical data evaluating the ability of a single radiologist using LN-1000 to find suspicious and actionable lesions, compared with a group of radiologists unaided by CAD, according to R2 Technologies...
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