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U.S. Department of Health and Human Services

Recognized Consensus Standards

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Recognition List Number: 013 FR Publication Date: 10/31/2005 

Part B: Supplementary Information

Recognition Number 12-6: IEC 60806 (R1984), determination of the maximum symmetrical radiation field from a rotating anode x-ray tube for medical diagnosis. (Radiology)

Date of Standard: 1984. 
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 DEVICE EVALUATION (ODE)
Devices Affected:
X-Ray Tubes, Diagnostic X-Ray Systems
Processes Affected:
510(k)
Type of Standard:
 Vertical, International
Extent of Recognition:
Complete standard and any annexes
Related CFR Citations and Product Codes:
Regulation
Number
Device Name Device
Class
Product
Code
§892.1760 Assembly, Tube Housing, X-Ray, Diagnostic Class 1 ITY
FDA Technical Contact:
 Robert Jennings
  FDA/CDRH/OSEL
  10903 New Hampshire Avenue Building 62, Room 3102
  Silver Spring MD 20993
  301/796-2539
  email: robertj.jennings@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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