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U.S. Department of Health and Human Services

Product Classification

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Device source, brachytherapy, radionuclide
Regulation Description Radionuclide brachytherapy source.
Regulation Medical Specialty Radiology
Review Panel Radiology
Product CodeKXK
Premarket Review Office of In Vitro Diagnostics and Radiological Health (OIR)
Submission Type 510(k)
Regulation Number 892.5730
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Guidance Document
  • Guidance for the Submission of Premarket Notifications for Photon-Emitting Brachytherapy Sources
Implanted Device? Yes
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible