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U.S. Department of Health and Human Services

Product Classification

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Device device, beam limiting, teletherapy, radionuclide
Regulation Description Radionuclide radiation therapy system.
Regulation Medical Specialty Radiology
Review Panel Radiology
Product CodeIWD
Premarket Review Office of Radiological Health (OHT8)
Radiological Imaging and Radiation Therapy Devices (DHT8C)
Submission Type 510(k)
Regulation Number 892.5750
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
Recognized Consensus Standards
Third Party Review
Accredited Persons
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