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U.S. Department of Health and Human Services

Recognized Consensus Standards

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Recognition List Number: 026 FR Publication Date: 02/28/2011 

Part B: Supplementary Information

Recognition Number 12-226: IEC 61223-2-6 Second Edition 2006-11, evaluation and routine testing in medical imaging departments - part 2-6: constancy tests - imaging performance of computed tomography x-ray equipment. (Radiology)

Date of Standard: 2006. 
Address of Standards Development Organization:
 International Electrotechnical Commission (IEC)
  3, Rue de Varembe'
  PO Box 131
  CH-1211 Geneva 20, 0
  SWITZERLAND
CDRH Offices and Divisions associated with recognized standards:
(1)OFFICE OF IN VITRO DIAGNOSTICS AND RADIOLOGICAL HEALTH (OIR)
(2)
(3)OFFICE OF COMPLIANCE (OC)
DIVISION OF ENFORCEMENT B (DOEB)
Devices Affected:
Computed Tomography X-Ray Systems
Processes Affected:
510(k), PMA, IDE, Compliance
Type of Standard:
 Vertical, International
Extent of Recognition:
Complete standard
Related CFR Citations and Product Codes:
Regulation
Number
Device Name Device
Class
Product
Code
§892.1750 System, X-Ray, Tomography, Computed Class 2 JAK
Relevant Guidance:
Guidance for Industry, FDA Staff and Third Parties - Provision for Alternate Measure of the 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/OIR
  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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