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Recognition List Number: 026 Publication Date: 03/18/2011 

Part B: SUPPLEMENTARY INFORMATION

Recognition Number 12-217: IEC 62083 Edition 2.0 2009-09, Medical electrical equipment - Requirements for the safety of radiotherapy treatment planning systems. (Radiology)

Date of Standard: 2009. 
Address of Standards Organization:
  International Electrotechnical Commission (IEC)
  3, Rue de Varembe'
  PO Box 131
  CH-1211 Geneva 20, 0
  SWITZERLAND
CDRH Offices and Divisions Associated with Recognized Standards:
(1)OFFICE OF IN VITRO DIAGNOSTICS AND RADIOLOGICAL HEALTH (OIR)
(2)OFFICE OF COMMUNICATION EDUCATION AND RADIATION PROGRAM (OCER)
DIVISION OF MAMMOGRAPHY QUALITY AND RADIATION PROGRAMS (DMQRP)
Devices Affected:
Radiotherapy Treatment Planning Systems
Processes Affected:
510(k), PMA, PDP, IDE, HDE
Type of Standard:
 International, Vertical
Extent of Recognition:
Complete standard and any annexes with specific national alterations
Related CFR Citations and Product Codes:
Regulation
Number		 Device Name Device
Class		 Product
Code
§892.5050 Accelerator, Linear, Medical Class 2 IYE
§892.5050 Accessory - Film Dosimetry System Class 2 MWW
§892.5050 Betatron, Medical Class 2 IYG
§892.5050 Cyclotron, Medical Class 2 IWK
§892.5050 Dosimeter, Ionizing Radiation, Implanted Class 2 NZT
§892.5050 Microtron, Medical Class 2 JAE
§892.5050 Synchrotron, Medical Class 2 IWM
§892.5050 System, Radiation Therapy, Charged-Particle, Medical Class 2 LHN
§892.5050 System,Planning,Radiation Therapy Treatment Class 2 MUJ
 
Regulation
Number		 Device Name Device
Class		 Product
Code
§892.5750 Device, Beam Limiting, Teletherapy, Radionuclide Class 2 IWD
§892.5750 System, Radiation Therapy, Radionuclide Class 2 IWB
 
Regulation
Number		 Device Name Device
Class		 Product
Code
§892.5900 Collimator, Dermatological, Therapeutic X-Ray Class 2 IYL
§892.5900 Collimator, High Voltage, Therapeutic X-Ray Class 2 IYK
§892.5900 Collimator, Low Voltage, Therapeutic X-Ray Class 2 IYJ
§892.5900 Collimator, Orthovoltage, Therapeutic X-Ray Class 2 IYI
§892.5900 Device, Beam Limiting, X-Ray, Therapeutic Class 2 KQA
§892.5900 Generator, Dermatological (Grenz Ray), Therapeutic X-Ray Class 2 IYH
§892.5900 Generator, High Voltage, X-Ray, Therapeutic Class 2 KPZ
§892.5900 Generator, Low Voltage, Therapeutic X-Ray Class 2 IYD
§892.5900 Generator, Orthovoltage, Therapeutic X-Ray Class 2 IYC
§892.5900 System, Therapeutic, X-Ray Class 2 JAD
 
Relevant Guidance:
There is no relevant guidance developed at this time.
FDA Technical Contact:
  Nancy Wersto
  FDA/CDRH/OIVD
  10903 New Hampshire Avenue Building 66, Room G320
  Silver Spring MD 20993
  301/796-6548
  Email: nancy.wersto@fda.hhs.gov
* In the United States, copies of this standard can be obtained from:
  American National Standards Institute (ANSI)*
  25 West 43rd Street
  4th Floor
  New York, NY 10036
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