Product Classification

• Device: calibrator, dose, radionuclide
• Regulation Description: Radionuclide dose calibrator.
• Regulation Medical Specialty: Radiology
• Review Panel: Radiology
• Product Code: KPT
• Premarket Review: Office of Radiological Health (OHT8); Division of Radiological Imaging and Radiation Therapy Devices (DHT8C)
• Submission Type: 510(k)
• Regulation Number: 892.1360
• 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 Standard

• 12-141 IEEE N42.13-2004
  Calibration and Usage of "Dose Calibrator" Ionization Chambers for the Assay of Radionuclides

Third Party Review

• Eligible for 510(k) Third Party Review Program

Accredited Persons

• center for measurement standards of industrial
• global quality and regulatory services
• regulatory technology services, llc
• third party review group, llc