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NCT02383420 · ClinicalTrials.gov registry record · NA
Clinical Evaluation of the Carestream PRO 3543 and PRO 3543C Digital Detectors
A NA study, sponsored by Carestream Health.
- Completed
- Registry status
- NA
- Development phase
- 23
- Enrollment target
NCT02383420 is a NA study that has completed, run by Carestream Health. The registered enrollment target is 23 participants.
The verdict
NCT02383420, a NA study, has completed, sponsored by Carestream Health.
- COMPLETED
- Registry status
- NA
- Development phase
- 23 participants
- Enrollment target
Study 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.
Interventions
- RADIATION Radiation
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 23 participants |
| Start Date | 2015-02 |
| Est. Completion | 2015-04 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02383420
The ClinicalTrials.gov registry entry for NCT02383420 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 23 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Carestream Health, which has 4 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Radiation is the first listed.
NCT02383420 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02383420 about?
NCT02383420 is a clinical study titled "Clinical Evaluation of the Carestream PRO 3543 and PRO 3543C Digital Detectors". 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...
What is the current status of trial NCT02383420?
This trial is currently completed. It is a NA study. The enrollment target is 23 participants. The study started on 2015-02. Estimated completion is 2015-04.
What interventions are being tested in trial NCT02383420?
The interventions under investigation include: Radiation (RADIATION).
Who is sponsoring clinical trial NCT02383420?
This trial is sponsored by Carestream Health, which has 4 total clinical trials registered on ClinicalTrials.gov.
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