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U.S. Department of Health and Human Services

Product Classification

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Device block, beam-shaping, radiation therapy
Regulation Description Radiation therapy beam-shaping block.
Regulation Medical Specialty Radiology
Review Panel Radiology
Product CodeIXI
Premarket Review Office of In Vitro Diagnostics and Radiological Health (OIR)
Division of Radiological Health (DRH)
Submission Type 510(k)
Regulation Number 892.5710
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Reporting
Eligible
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review
Accredited Persons
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