Product Classification

• Device: needle, isotope, gold, titanium, platinum
• Regulation Description: Radionuclide brachytherapy source.
• Regulation Medical Specialty: Radiology
• Review Panel: Radiology
• Product Code: IWF
• 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

• Eligible for 510(k) Third Party Review Program

Accredited Persons

• global quality and regulatory services
• regulatory technology services, llc
• third party review group, llc