Product Classification

• Device: system, applicator, radionuclide, remote-controlled
• Regulation Description: Remote controlled radionuclide applicator system.
• Regulation Medical Specialty: Radiology
• Review Panel: Radiology
• Product Code: JAQ
• Premarket Review: Office of Radiological Health (OHT8); Radiological Imaging and Radiation Therapy Devices (DHT8C)
• Submission Type: 510(k)
• Regulation Number: 892.5700
• 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

Recognized Consensus Standards

• 12-259 IEC 61674 Edition 2.0 2012-11
  Medical electrical equipment -- Dosimeters with ionization chambers and/or semiconductor detectors as used in X-ray diagnostic imaging
• 12-272 IEC 60601-2-17 Edition 3.0 2013-11
  Medical electrical equipment - Part 2-17: Particular requirements for the safety of automatically-controlled brachytherapy afterloading equipment

Third Party Review

Not Third Party Eligible