Clinical Image Evaluation for the DREX-KL80 Imaging System

Toshiba Medical Systems

Status: Completed

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

Treatments: Device: Radiography and Fluoroscopy Imaging System

Study type: Observational

Funder types: Industry

Identifiers

NCT01318772

KH-001

Details and patient eligibility

About

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.

Enrollment: 42 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

42 participants in 1 patient group

Fluoroscopy and Angiography Procedure

Description:

Patient that have been scheduled for routine diagnostic fluoroscopy and angiography procedures by their physician.

Treatment:

Device: Radiography and Fluoroscopy Imaging System