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) ("investigational device") as compared to the currently marketed Carestream DRX-1 Detector ("predicate device"). The evaluation will consist primarily of comparing the diagnostic image quality of double-imaged pediatric and adult cadaver studies and adult live human subject studies acquired under the same exposure technique for similar detector types (i.e. comparing DRX-1 GOS predicate with DRX Plus GOS) or exposure adjusted technique when different detector types are compared.

Under the same position and radiological technique, pediatric and adult cadaver studies, and adult live human subject studies, using double-exposed images will be acquired to evaluate the diagnostic image quality of the investigational device versus the predicate device. Target images will be assembled and reviewed in a side-by-side Comparative Evaluation to statistically confirm the findings of this evaluation.

The live human subject portion of this study will be performed on healthy volunteers. Each volunteer will sign an Informed Consent after which they will have two (2) x-rays taken. The first x-ray will follow standard technique using the cleared predicate detector currently in use at the site. Following the first x-ray, we will take one additional x-ray of the same part of the body with one (1) of the investigational detectors. The x-ray from the investigational detector will not be used to diagnose.

If the x-ray obtained by the standard DR x-ray detector shows any unforeseen, unusual or abnormal findings, these findings will be communicated to the subject and their doctor by USPS mail.

Reason for Observational Study Type: There are three (3) physical detectors being used in this study. Each detector is 35 centimeters by 43 centimeters. None of the subjects will given a detector.