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U.S. Department of Health and Human Services

Product Classification

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Device camera, x-ray, fluorographic, cine or spot
Regulation Description Cine or spot fluorographic x-ray camera.
Regulation Medical Specialty Radiology
Review Panel Radiology
Product CodeIZJ
Premarket Review Office of Radiological Health (OHT8)
Radiological Imaging Devices and Electronic Products (DHT8B)
Submission Type 510(k)
Regulation Number 892.1620
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
Third Party Review
Accredited Persons
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