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U.S. Department of Health and Human Services

Product Classification

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Device image-intensified fluoroscopic x-ray system, mobile
Regulation Description Image-intensified fluoroscopic x-ray system.
Definition Fluoroscopy of the human body.
Physical State Hardware
Technical Method X-ray transmission through human body
Target Area Human Body
Regulation Medical Specialty Radiology
Review Panel Radiology
Product CodeOXO
Premarket Review Office of In Vitro Diagnostics and Radiological Health (OIR)
Submission Type 510(k)
Regulation Number 892.1650
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Third Party Review Not Third Party Eligible
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