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U.S. Department of Health and Human Services

Product Classification

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Device x-ray angiographic imaging based coronary vascular simulation software device
Regulation Description Angiographic x-ray system.
Definition X-ray angiographic imaging based coronary vascular simulation software device is a prescription device that provides an image analysis tool to assess blood flow in the coronary vascular system using X-ray angiographic imaging data. X-ray angiographic imaging based coronary vascular simulation software device solves algorithms and yields simulation-based metrics for certain cardiology applications. X-ray angiographic imaging based coronary vascular simulation software device cannot be used alone for clinical decision making and clinical management, and is a tool intended to generate results for use and review by a qualified clinician.
Physical State Software device that receives X-ray angiographic image data as an input and provides the user with an image analysis tool that cannot be used alone for clinical decision making and clinical management.
Technical Method Analyzes X-ray angiographic data using fluid dynamic simulation algorithms to yield simulation-based metrics for certain cardiology applications.
Target Area X-ray angiographic images of the cardiac vasculature.
Regulation Medical Specialty Radiology
Review Panel Radiology
Product CodeQHA
Premarket Review Office of In Vitro Diagnostics and Radiological Health (OIR)
Submission Type 510(k)
Regulation Number 892.1600
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Reporting
Ineligible
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible
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