Comparison of two indirect detection flat panel imagers

摘要

To obtain clearance for the use of a new flat-panel indirect detection imager, the FDA required the manufacturer to provide evidence of the image quality. To this end, two sets of observer studies were conducted, one in which images from the detector was compared side by side with images from an approved detector, and a second set in which each individual image was scored for image contrast, noise, and resolution. Statistical analysis of the results showed that there was not a significant difference in the image quality produced by the two detectors. FDA 510k clearance was granted in May 2013.