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U.S. Department of Health and Human Services

Product Classification

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Device assembly, tube housing, x-ray, therapeutic
Regulation Description Therapeutic x-ray tube housing assembly.
Regulation Medical Specialty Radiology
Review Panel Radiology
Product CodeITZ
Premarket Review Office of Radiological Health (OHT8)
Radiological Imaging and Radiation Therapy Devices (DHT8C)
Submission Type 510(k)
Regulation Number 892.5930
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 Standard
Third Party Review
Accredited Persons
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