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U.S. Department of Health and Human Services

Product Classification

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Device cabinet, x-ray system
Regulation Description Stationary x-ray system.
Regulation Medical Specialty Radiology
Review Panel Radiology
Product CodeMWP
Premarket Review Office of Radiological Health (OHT8)
Division of Imaging Devices and Electronic Products (DHT8B)
Submission Type 510(k)
Regulation Number 892.1680
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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