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U.S. Department of Health and Human Services

Product Classification

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Device system, simulation, radiation therapy
Regulation Description Radiation therapy simulation system.
Regulation Medical Specialty Radiology
Review Panel Radiology
Product CodeKPQ
Premarket Review Office of In Vitro Diagnostics and Radiological Health (OIR)
Submission Type 510(k)
Regulation Number 892.5840
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Recognized Consensus Standards
Third Party Review
Accredited Persons

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