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U.S. Department of Health and Human Services

Product Classification

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Device industrial x-ray
Definition An x-ray system used for industrial purposes to which the cabinet x-ray performance standard does not apply (21 cfr 1020.40).
Product CodeRBS
Device Class Not Classified
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Reporting
Ineligible
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible
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