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U.S. Department of Health and Human Services

Product Classification

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Device generator, dermatological (grenz ray), therapeutic x-ray
Regulation Description X-ray radiation therapy system.
Regulation Medical Specialty Radiology
Review Panel Radiology
Product CodeIYH
Premarket Review Office of In Vitro Diagnostics and Radiological Health (OIR)
Submission Type 510(k)
Regulation Number 892.5900
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Recognized Consensus Standards
Third Party Review
Accredited Persons

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