Clinical Image Evaluation for the DREX-KL80 Imaging System

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

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.

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