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U.S. Department of Health and Human Services

Product Classification
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Device software for visualization of vascular anatomy and intravascular devices
Regulation Description Medical image management and processing system.
Definition Visualization and measurement of blood vessels and intravascular devices for preoperational planning.
Physical State Software
Technical Method Processing radiographic data to visualize vascular anatomy and intravascular devices.
Target Area Vasculature
Regulation Medical Specialty Radiology
Review Panel Cardiovascular
Product CodePZO
Premarket Review Office of Cardiovascular Devices (OHT2)
Circulatory Support, Structural and Vascular Devices (DHT2B)
Submission Type 510(k)
Regulation Number 892.2050
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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