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U.S. Department of Health and Human Services

Recognized Consensus Standards

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Recognition List Number: 031 FR Publication Date: 08/05/2013 

Part B: Supplementary Information

Recognition Number 12-204: IEC 60601-2-28 Edition 2.0 2010-03, medical electrical equipment - part 2-28: particular requirements for the basic safety and essential performance of x-ray tube assemblies for medical diagnosis. (Radiology)

Date of Standard: 2010. 
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:
Diagnostic X-Ray Tube Housing Assembly
Processes Affected:
510(k), PMA, PDP, IDE, HDE
Type of Standard:
 Vertical, International
Extent of Recognition:
Complete standard and any annexes with specific national alterations for areas not covered by 21 CFR Subchapter J (1000, et. al.)

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:
 Richard V. Kaczmarek
  FDA/CDRH/OIR
  10903 New Hampshire Avenue Building 66, Room 4536
  Silver Spring MD 20993
  301/796-5891
  email: richard.kaczmarek@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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