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U.S. Department of Health and Human Services

Product Classification

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Device system, radiation therapy, neutron, medical
Regulation Description Medical neutron radiation therapy system.
Regulation Medical Specialty Radiology
Review Panel Radiology
Product CodeIWL
Premarket Review Office of In Vitro Diagnostics and Radiological Health (OIR)
Submission Type 510(k)
Regulation Number 892.5300
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Recognized Consensus Standard
Third Party Review
Accredited Persons

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