Device, Beam Limiting, Teletherapy, Radionuclide

Device Code: 5281

Product Code(s): IWD

Device Classification Information

• Device Type ID: 5281
• Device Name: Device, Beam Limiting, Teletherapy, Radionuclide
• Regulation Description: Radionuclide Radiation Therapy System.
• Regulation Medical Specialty: Radiology
• Review Panel: Radiology
• Premarket Review: Office Of In Vitro Diagnostics And Radiological Health (OIR)
• Submission Type: 510(k)
• CFR Regulation Number: 892.5750 [🔎]
• FDA Device Classification: Class 2 Medical Device
• Product Code: IWD
• GMP Exempt: No
• Summary MR: Eligible
• Implanted Device: No
• Life Support Device: No
• Third Party Review: Eligible For Accredited Persons Expansion Pilot Program

Recognized Standards

• 12-217 IEC 62083 Edition 2.0 2009-09
  Medical Electrical Equipment - Requirements For The Safety Of Radiotherapy Treatment Planning 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
• 12-259 IEC 61674 Edition 2.0 2012-11
  Medical Electrical Equipment -- Dosimeters With Ionization Chambers And/or Semiconductor Detectors As Used In X-ray Diagnostic Imaging
• 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

Total Product Life Cycle

• Device Type ID: 5281
• Device: Device, Beam Limiting, Teletherapy, Radionuclide
• Product Code: IWD
• FDA Device Classification: Class 2 Medical Device
• Regulation Description: Radionuclide Radiation Therapy System.
• CFR Regulation Number: 892.5750 [🔎]

TPLC Last Update: 2019-04-02 21:03:35