NCT01318772

Clinical Image Evaluation for the DREX-KL80 Imaging System

Clinical Image Evaluation for the KALARE (DREX-KL80) With New Digital Camera and Image Processor

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 42 (actual)
• Sponsor: Toshiba America Medical Systems, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

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.

Conditions

• Obtain Diagnostic Images With the New Digital Camera and Image Processor for Evaluation.

Interventions

Type	Name	Description
DEVICE	Radiography and Fluoroscopy Imaging System	KALARE (DREX-KL80) is a new high resolution digital system designed for digital spot imaging, with the primary goal to address R/F and DSA clinical applications and produce images in a digital format. The system includes a new digital camera and a new image processor.

Timeline

• Start date: 2010-12-01
• Primary completion: 2011-01-01
• Completion: 2011-01-01
• First posted: 2011-03-18
• Last updated: 2011-03-18

Locations

1 site across 1 country: United States