Product Classification

• Device: dosimeter, ionizing radiation, implanted
• Regulation Description: Medical charged-particle radiation therapy system.
• Definition: Verify radiation dose to organs from external radiation therapy.
• Physical State: glass encapsulated electronics
• Technical Method: Radiation causes change in MOSFET diode that is perportional to dose which can be interigated by external reader.
• Target Area: Radiation therapy target organ
• Regulation Medical Specialty: Radiology
• Review Panel: Radiology
• Product Code: NZT
• 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?: Yes
• 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
• 12-267 IEC 61217 Edition 2.0 2011-12
  Radiotherapy equipment - Coordinates, movements, and scales
• 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