Product Classification

• Device: needle, isotope, reprocessed
• Regulation Description: Radionuclide brachytherapy source.
• Definition: Reprocessing validation data for this device type must be included in a 510(k) submission. (70 FR 56911, available at https://www.govinfo.gov/content/pkg/FR-2005-09-29/pdf/05-19510.pdf).
• Regulation Medical Specialty: Radiology
• Review Panel: Radiology
• Product Code: NMP
• Premarket Review: Office of Radiological Health (OHT8); Radiological Imaging and Radiation Therapy Devices (DHT8C)
• Submission Type: 510(k)
• Regulation Number: 892.5730
• 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

Guidance Document

• Guidance for the Submission of Premarket Notifications for Photon-Emitting Brachytherapy Sources

Third Party Review

Not Third Party Eligible