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
• Submission Type: 510(k)
• Regulation Number: 892.5700
• Device Class: 2
• Total Product Life Cycle (TPLC): TPLC Product Code Report
• GMP Exempt?: No

Recognized Consensus Standards

• IEC 60601-2-17 (2004) Medical electrical equipment - Part 2-17: Particular requirements for the safety of automatically-controlled brachytherapy afterloading equipment
• IEC 61674(1997)(2002) Amendment 1, Medical electrical equipment - Dosimeters with ionization chambers and/or semi-conductor detectors as used in X-ray diagnostic imaging

Third Party Review

• Eligible for Accredited Persons Expansion Pilot Program

Accredited Persons

• dekra certification b.v.
• intertek testing services
• regulatory technology services, llc
• tuv sud america inc.
• underwriters laboratories, inc.