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U.S. Department of Health and Human Services

Product Classification

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Device veterinary x-ray therapy system
Definition Equipment using x-rays to provide therapy in veterinary applications.
Product CodeRCK
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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