Expired Study
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Las Vegas, Nevada 89109


Purpose:

The purpose of this study is to acquire the clinical data required by the United States Food and Drug Administration (USFDA) for 510(k) submission, for approval of a new high resolution imaging system for fluoroscopy/radiography. It is expected that the new KALARE (DREX-KL80)high resolution imaging system will meet the design specifications. A minimum of 30 cases will be submitted for evaluation of claims for intended clinical applications.


Criteria:

Inclusion Criteria: - Male and female patient 18 years and older - Not pregnant - Not a safety risk patient Exclusion Criteria: - Male and female patient under 18 years old - Pregnant subjects - High safety risk subjects - Subjects and/or Legal Guardian Unable to provide informed consent


NCT ID:

NCT01318772


Primary Contact:

Principal Investigator
Mark Winkler, M.D.
Stienberg Diagnostic Meidcal Imaging (SDMI)


Backup Contact:

N/A


Location Contact:

Las Vegas, Nevada 89109
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: August 31, 2019

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