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U.S. Department of Health and Human Services

Product Classification
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Device system, therapeutic, x-ray
Regulation Description X-ray radiation therapy system.
Regulation Medical Specialty Radiology
Review Panel Radiology
Product CodeJAD
Premarket Review Office of Radiological Health (OHT8)
Radiological Imaging and Radiation Therapy Devices (DHT8C)
Submission Type 510(k)
Regulation Number 892.5900
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 Not Third Party Eligible
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