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Recognition List Number: 024 Publication Date: 06/10/2010 

Part B: SUPPLEMENTARY INFORMATION

Recognition Number 12-203: IEC 60601-2-44 Edition 3.0 2009-02, Medical electrical equipment - Part 2-44: Particular requirements for the basic safety and essential performance of X-ray equipment for computed tomography. (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 Office and Division Associated with Recognized Standards:
OFFICE OF IN VITRO DIAGNOSTICS AND RADIOLOGICAL HEALTH (OIR)
Devices Affected:
Computer Tomograhy Systems
Processes Affected:
510(k), PMA, IDE, Compliance
Type of Standard:
 Vertical, International
Extent of Recognition:
Complete standard including annexes.

Transition:
FDA recognition of IEC 60601-2-44 (2002-11) is hereby superseded by recognition of IEC 60601-2-44 Edition 3.0 2009-02 Medical electrical equipment - Part 2-44: Particular requirements for the basic safety and essential performance of X-ray equipmenet for computed tomography. FDA will accept declaration of conformity, in support of premarket submissions, to IEC 60601-2-44 (2002-11) until June 30, 2013. After this transitional period, declaration of conformity to Ed. 2.1:2002-11 of this standard will not not accepted.
Related CFR Citations and Product Codes:
Regulation
Number		 Device Name Device
Class		 Product
Code
§892.2050 Lung Computed Tomography System, Computer-Aided Detection Class 2 OEB
 
Regulation
Number		 Device Name Device
Class		 Product
Code
§892.1750 System, X-Ray, Tomography, Computed Class 2 JAK
 
Relevant Guidance:
Guidance for Industry, FDA Staff and Third Parties - Provision for Alternate Measure of teh Computed Tomography Dose Index (CTDI) to Assure Compliance with the Dose Information Requirements of the Federal Performance Standard for Computed Tomography. Document issued on October 20, 2006
FDA Technical Contact:
  Stanley H. Stern
  FDA/CDRH/OCER
  10903 New Hampshire Avenue Building 66, Room 4538
  Silver Spring MD 20993
  301/796-5894
  Email: stanley.stern@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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