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U.S. Department of Health and Human Services

Recognized Consensus Standards

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Recognition List Number: 028 FR Publication Date: 03/16/2012 

Part B: Supplementary Information

Recognition Number 12-241: IEC 62274 First Edition 2005-05, medical electrical equipment - safety of radiotherapy record and verify systems. (Radiology)

Date of Standard: 2005. 
Address of Standards Development Organization:
 International Electrotechnical Commission (IEC)
  3, Rue de Varembe'
  PO Box 131
  CH-1211 Geneva 20, 0
  SWITZERLAND
CDRH Office and Division associated with recognized standards:
OFFICE OF IN VITRO DIAGNOSTICS AND RADIOLOGICAL HEALTH (OIR)
Devices Affected:
Radiotherapy record and verify systems
Processes Affected:
510(k)
Type of Standard:
 Vertical, International
Extent of Recognition:
Complete standard
Related CFR Citations and Product Codes:
Regulation
Number
Device Name Device
Class
Product
Code
§892.5050 Accelerator, Linear, Medical Class 2 IYE
§892.5050 System, Radiation Therapy, Charged-Particle, Medical Class 2 LHN
§892.5750 System, Radiation Therapy, Radionuclide Class 2 IWB
§892.5900 System, Therapeutic, X-Ray Class 2 JAD
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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