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U.S. Department of Health and Human Services

Product Classification

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Device interventional fluoroscopic x-ray system
Regulation Description Image-intensified fluoroscopic x-ray system.
Definition Interventional fluoroscopy.
Physical State Fluoroscopic X-Ray system
Technical Method Fluoroscopy
Target Area Human body
Regulation Medical Specialty Radiology
Review Panel Radiology
Product CodeOWB
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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