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U.S. Department of Health and Human Services

Product Classification
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Device radiological image processing software for ablation therapy planning and evaluation
Regulation Description Medical image management and processing system.
Definition To provide radiological image processing tools for planning, monitoring, and evaluating ablation therapy.
Physical State Software application and/or firmware, system components and accessories
Technical Method Processing radiographic data to assist in the planning, monitoring, and evaluation of ablation therapy. Software that controls ablation devices is not within scope of this product code.
Target Area Human-derived imaging products
Regulation Medical Specialty Radiology
Review Panel Radiology
Product CodeQTZ
Premarket Review Office of Radiological Health (OHT8)
Radiological Imaging Devices and Electronic Products (DHT8B)
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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