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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 In Vitro Diagnostics and Radiological Health (OIR)
Submission Type 510(k)
Regulation Number 892.5930
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Recognized Consensus Standard
Third Party Review
Accredited Persons

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