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

Completed · Not applicable

Conditions studied: Healthy

In brief

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.

Key facts

Study ID

NCT02337959

Run by

Carestream Health, Inc.

People needed

27

Starts

2015-01-01

Expected to finish

2015-03-01

Last updated by the study team

2016-04-18

Who can join

Age: 21 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• X-ray images of nearly identical positioning and exposure
• No visible image artifacts
• Subject 21years or older
• Subject has provided informed consent
• Subject is in good general health
• Subject is able to stand for two (2) x-rays

You may not qualify if…

• Images that are not clinically acceptable for clinical radiographic reading as determined by the Principal Investigator.
• Subject is pregnant or suspicious of being pregnant
• Not able or willing to provide Informed Consent, or consent is withdrawn
• Not able to collect all required case information
• Subject has a history of high radiation exposure:
• Has undergone radiation therapy
• Has had two (2) or more CT scans within the past year

Where it is running

• University of Rochester — Rochester, New York, United States

Full record on ClinicalTrials.gov

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