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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 Radiological Health (OHT8)
Radiological Imaging Devices and Electronic Products (DHT8B)
Submission Type 510(k)
Regulation Number 892.1650
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Reporting
Eligible
Implanted Device? No
Life-Sustain/Support Device? No
Recognized Consensus Standards
Guidance Document
Third Party Review
Accredited Persons
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