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U.S. Department of Health and Human Services

Product Classification

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Device camera, scintillation (gamma)
Regulation Description Scintillation (gamma) camera.
Regulation Medical Specialty Radiology
Review Panel Radiology
Product CodeIYX
Premarket Review Office of In Vitro Diagnostics and Radiological Health (OIR)
Submission Type 510(k)
Regulation Number 892.1100
Device Class 1
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Recognized Consensus Standard
Third Party Review
Accredited Persons

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