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
• Premarket Review: Office of Radiological Health (OHT8); Radiological Imaging and Radiation Therapy Devices (DHT8C)
• Submission Type: 510(k)
• Regulation Number: 892.5050
• 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 Standards

• 12-217 IEC 62083 Edition 2.0 2009-09
  Medical electrical equipment - Requirements for the safety of radiotherapy treatment planning systems
• 12-241 IEC 62274 First Edition 2005-05
  Medical electrical equipment - Safety of radiotherapy record and verify systems
• 12-255 IEC 60601-2-11 Edition 3.0 2013-01
  Medical electrical equipment - Part 2-11: Particular requirements for the basic safety and essential performance of gamma beam therapy equipment
• 12-267 IEC 61217 Edition 2.0 2011-12
  Radiotherapy equipment - Coordinates, movements, and scales
• 12-304 IEC 60731 Edition 3.1 2016-04
  Consolidated Version Medical electrical equipment - Dosimeters with ionization chambers as used in radiotherapy
• 12-307 AAMI RT2:2017
  Radiation therapy readiness check
• 12-318 IEC 60601-2-64 Edition 1.0 2014-09
  Medical electrical equipment - Part 2-64: Particular requirements for the basic safety and essential performance of light ion beam medical electrical equipment
• 12-319 IEC 60601-2-68 Edition 1.0 2014-09
  Medical electrical equipment - Part 2-68: Particular requirements for the basic safety and essential performance of X-ray-based image-guided radiotherapy equipment for use with electron accelerators, light ion beam therapy equipment and radionuclide beam therapy equipment
• 12-320 IEC 62667 Edition 1.0 2017-08
  Medical electrical equipment - Medical light ion beam equipment - Performance characteristics
• 12-338 IEC 60601-2-1 Edition 4.0 2020-10
  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

Third Party Review

Not Third Party Eligible