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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fluoroscopy and Angiography Procedure | Patient that have been scheduled for routine diagnostic fluoroscopy and angiography procedures by their physician. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Radiography and Fluoroscopy Imaging System | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Collection of representative images | Collect 30 to 60 represenative images to support pre-market submission. | Estimated completion 4 weeks after start of the study |
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Inclusion Criteria:
Exclusion Criteria:
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Male and female patient 18 years and older
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| Name | Affiliation | Role |
|---|---|---|
| Mark Winkler, M.D. | Stienberg Diagnostic Meidcal Imaging (SDMI) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| SDMI | Las Vegas | Nevada | 89109 | United States |
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| ID | Term |
|---|---|
| D011859 | Radiography |
| ID | Term |
|---|---|
| D003952 | Diagnostic Imaging |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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