Clinical Evaluation of DRX Plus 3543 and DRX Plus 3543C Digital Detectors

The purpose of this clinical study is to evaluate the imaging performance of the DRX Plus 3543 and DRX Plus 3543C Detectors (flat panel digital imaging devices) as compared to the currently marketed Carestream DRX-1 Detector. The results of this study will be included in a Traditional 510(k) FDA Submission to obtain clearance to market the new detectors in the US. The study was designed in accordance with the FDA Guidance titled \"Guidance for the Submission of 510(k)\'s for Solid State X-ray Imaging Devices\", issued on August 6, 1999.