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U.S. Department of Health and Human Services

Product Classification
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Device angiographic coronary vascular physiologic simulation software
Regulation Description Coronary vascular physiologic simulation software device.
Definition An angiographic coronary vascular physiologic simulation software device is intended to aid in the identification of functionally significant cardiovascular disease.
Physical State Software
Technical Method Performs perioperative analysis of angiographic imaging data to simulate blood flow in the coronary vasculature.
Target Area Coronary Vasculature
Regulation Medical Specialty Cardiovascular
Review Panel Cardiovascular
Product CodeQEK
Premarket Review Office of Cardiovascular Devices (OHT2)
Cardiac Electrophysiology, Diagnostics, and Monitoring Devices (DHT2A)
Submission Type 510(k)
Regulation Number 870.1415
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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