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U.S. Department of Health and Human Services

Product Classification
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Device cabinet x-ray, industrial
Definition A cabinet x-ray system used for quality control, non-destructive testing, or some other industrial purpose.
Product CodeRCE
Device Class Not Classified
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? Yes
    Note: This device is also exempted from the GMP regulation, except for general requirements concerning records (820.180) and complaint files (820.198), as long as the device is not labeled or otherwise represented as sterile.
Summary Malfunction
Reporting		 Ineligible
Third Party Review Not Third Party Eligible
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