Product Classification

• Device: collimator, orthovoltage, therapeutic x-ray
• Regulation Description: X-ray radiation therapy system.
• Regulation Medical Specialty: Radiology
• Review Panel: Radiology
• Product Code: IYI
• Premarket Review: Office of Radiological Health (OHT8); Radiological Imaging and Radiation Therapy Devices (DHT8C)
• Submission Type: 510(k)
• Regulation Number: 892.5900
• 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
• 12-304 IEC 60731 Edition 3.1 2016-04
  Consolidated Version Medical electrical equipment - Dosimeters with ionization chambers as used in radiotherapy

Third Party Review

• Eligible for 510(k) Third Party Review Program

Accredited Persons

• global quality and regulatory services
• regulatory technology services, llc
• third party review group, llc