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U.S. Department of Health and Human Services

Product Classification

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Device couch, radiation therapy, powered
Regulation Description Powered radiation therapy patient support assembly.
Regulation Medical Specialty Radiology
Review Panel Radiology
Product CodeJAI
Premarket Review Office of In Vitro Diagnostics and Radiological Health (OIR)
Submission Type 510(k)
Regulation Number 892.5770
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Third Party Review
Accredited Persons

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