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U.S. Department of Health and Human Services

Product Classification

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Device system, imaging, x-ray, electrostatic
Regulation Description Electrostatic x-ray imaging system.
Regulation Medical Specialty Radiology
Review Panel Radiology
Product CodeIXK
Premarket Review Office of In Vitro Diagnostics and Radiological Health (OIR)
Submission Type 510(k)
Regulation Number 892.1630
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Third Party Review
Accredited Persons

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