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U.S. Department of Health and Human Services

Product Classification

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Device c-arm fluoroscopic x-ray system
Regulation Description Image-intensified fluoroscopic x-ray system.
Definition Fluoroscopic x-ray system in which the image receptor and x-ray tube housing assembly are connected or coordinated to maintain a spatial relationship. Such a system allows a change in the direction of the beam axis with respect to the patient without moving the patient.
Regulation Medical Specialty Radiology
Review Panel Radiology
Product CodeRCC
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
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review
Accredited Persons