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U.S. Department of Health and Human Services

Product Classification

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Device coronary vascular physiologic simulation software
Regulation Description Coronary vascular physiologic simulation software device.
Definition A coronary vascular physiologic simulation software device is intended to aid in the identification of functionally significant cardiovascular disease.
Physical State Software
Technical Method Performs offline analysis of pre-existing imaging data to simulate blood flow in the coronary vasculature.
Target Area Coronary Vasculature
Regulation Medical Specialty Cardiovascular
Review Panel Cardiovascular
Product CodePJA
Premarket Review 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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