Product Classification

• Device: calibrator, dose, radionuclide
• Regulation Description: Radionuclide dose calibrator.
• Regulation Medical Specialty: Radiology
• Review Panel: Radiology
• Product Code: KPT
• Submission Type: 510(k)
• Regulation Number: 892.1360
• Device Class: 2
• Total Product Life Cycle (TPLC): TPLC Product Code Report
• GMP Exempt?: No

Recognized Consensus Standard

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

Guidance Document

• Guidance for the Submission of Premarket Notifications for Radionuclide Dose Calibrators; Final

Third Party Review

• Eligible for Accredited Persons Program

Accredited Persons

• bsi healthcare
• center for measurement standards of industrial
• dekra certification b.v.
• intertek testing services
• regulatory technology services, llc
• tuv sud america inc.
• underwriters laboratories, inc.