At a glance
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Clinical Evaluation of the Carestream PRO 3543 and PRO 3543C Digital Detectors
In Brief
A clinical study evaluating Radiation for Healthy. Completed, enrolled 23 participants across 1 site.
Detailed Summary
The purpose of this clinical study is to evaluate the imaging performance of the Carestream PRO 3543 Detector and Carestream PRO 3543C Detector (referred to as the "investigational devices") as compared to the currently marketed Carestream DRX-1 Detector (referred to as the "predicate device"). Both detectors are flat panel digital imaging devices. 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.
Study Details
Timeline
Interventions
Live subjects will receive two x-rays, one with predicate detector and one using the GOS or CsI investigational detector. Multiple exams (head, chest, legs, etc) were made on the cadavers. Each exam area received one x-ray using the predicate detector and two x-rays using both the GoS and the CsI investigational detector.