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U.S. Department of Health and Human Services

Product Classification

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Device cyclotron, medical
Regulation Description Medical charged-particle radiation therapy system.
Regulation Medical Specialty Radiology
Review Panel Radiology
Product CodeIWK
Premarket Review Office of In Vitro Diagnostics and Radiological Health (OIR)
Submission Type 510(k)
Regulation Number 892.5050
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Recognized Consensus Standards
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review
Accredited Persons