Product Classification

• Device: system, radiation therapy, charged-particle, medical
• Regulation Description: Medical charged-particle radiation therapy system.
• Regulation Medical Specialty: Radiology
• Review Panel: Radiology
• Product Code: LHN
• Submission Type: 510(k)
• Regulation Number: 892.5050
• Device Class: 2
• Total Product Life Cycle (TPLC): TPLC Product Code Report
• GMP Exempt?: No

Recognized Consensus Standards

• IEC 60601-2-1 Edition 3.0 2009-10 Medical electrical equipment - Part 2-1: Particular requirements for the basic safety and essential performance of electron accelerators in the range 1 MeV to 50 MeV
• IEC 62083 Edition 2.0 2009-09 Medical electrical equipment - Requirements for the safety of radiotherapy treatment planning systems
• IEC 60601-2-11 (1997)(2004) Amendment 1 - Medical electrical equipment - Part 2-11: Particular requirements for the safety of gamma beam therapy equipment
• IEC 60731 Edition 3.0 2011-02 Amendment 1, Medical electrical equipment - Dosimeters with ionization chambers as used in radiotherapy
• IEC 62274 First Edition 2005-05 Medical electrical equipment - Safety of radiotherapy record and verify systems
• IEC 60601-2-1 (1998) Amendment 1: 2002 Medical electrical equipment - Part 2-1: Particular requirements for the safety of electron accelerators in the range 1 MeV to 50 MeV
• 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.