Product Classification

• Device: system, simulation, radiation therapy
• Regulation Description: Radiation therapy simulation system.
• Regulation Medical Specialty: Radiology
• Review Panel: Radiology
• Product Code: KPQ
• Submission Type: 510(k)
• Regulation Number: 892.5840
• Device Class: 2
• Total Product Life Cycle (TPLC): TPLC Product Code Report
• GMP Exempt?: No

Recognized Consensus Standards

• IEC 60601-2-29 (1999) Medical electrical equipment - Part 2-29: Particular requirements for the basic safety and essential performance of radiotherapy simulators - Third Edition
• IEC 60601-2-29 Edition 3.0 2008-06 Medical electrical equipment - Part 2-29: Particular requirements for the basic safety and essential performance of radiotherapy simulators
• 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
• IEC 61217 (2008) Radiotherapy equipment - Coordinates, movements, and scales Consolidated Edition 1.2

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.