Clinical Evaluation of the Carestream PRO 3543 and PRO 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 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.

Key facts

Study ID

NCT02383420

Run by

Carestream Health, Inc.

People needed

23

Starts

2015-02-01

Expected to finish

2015-04-01

Last updated by the study team

2016-04-15

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 21 years or older
• Subject has provided informed consent
• Subject is in good general health (is able to be still to reduce the potential of motion in the images)
• 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
• Subject not able or willing to provide Informed Consent, or consent is withdrawn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:
• Subject has undergone radiation therapy
• Subject 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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