Obtain Diagnostic Images With the New Digital Camera and Image Processor for Evaluation.
Conditions
Brief 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.
Interventions
DEVICERadiography 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.
Sponsors
Toshiba America Medical Systems, Inc.
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Collection of representative images | Estimated completion 4 weeks after start of the study | Collect 30 to 60 represenative images to support pre-market submission. |
Countries
United States
Outcome results
None listed