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U.S. Department of Health and Human Services

Product Classification

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Device processor, radiographic-film, automatic
Regulation Description Automatic radiographic film processor.
Regulation Medical Specialty Radiology
Review Panel Radiology
Product CodeIXW
Premarket Review Office of In Vitro Diagnostics and Radiological Health (OIR)
Submission Type Enforcement Discretion
Regulation Number 892.1900
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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