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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 12-202: IEC 60601-2-43 - Ed. 2.0 2010-03, medical electrical equipment - part 2-43: particular requirements for the safety and essential performance of x-ray equipment for interventional procedures. (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:
X-ray Equipment Interventional Procedures
Processes Affected:
510(k), IDE, HDE
Type of Standard:
 International, Vertical
Extent of Recognition:
Complete standard

Related CFR Citations and Product Codes:
Regulation
Number
Device Name Device
Class
Product
Code
§892.1650 System, X-Ray, Fluoroscopic, Image-Intensified Class 2 JAA
§892.1680 Solid State X-Ray Imager (Flat Panel/Digital Imager) Class 2 MQB
FDA Technical Contact:
 Kish Chakrabarti
  FDA/CDRH/OIR
  10903 New Hampshire Avenue Building 66, Room G308
  Silver Spring MD 20993
  301/796-6539
  email: kish.chakrabarti@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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