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Recognized Consensus Standards

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Recognition List Number: 026 FR Publication Date: 03/18/2011 

Part B: Supplementary Information

Recognition Number 12-221: IEC 61223-3-4 First edition 2000-03, evaluation and routine testing in medical imaging departments - part 3-4: acceptance tests - imaging performance of dental x-ray. (Radiology)

Date of Standard: 2000. 
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)OFFICE OF DEVICE EVALUATION (ODE)
Devices Affected:
Dental X-ray equipment
Processes Affected:
510(k), PMA, Device Evaluation, Radiological Health Regulations
Type of Standard:
 Vertical, International
Extent of Recognition:
Complete standard
Related CFR Citations and Product Codes:
Regulation
Number
Device Name Device
Class
Product
Code
§872.1800 System,X-Ray,Extraoral Source,Digital Class 2 MUH
§872.1800 Unit, X-Ray, Extraoral With Timer Class 2 EHD
§872.1810 Unit, X-Ray, Intraoral Class 2 EAP
FDA Technical Contacts:
 William Jung
  FDA/CDRH/OIR
  10903 New Hampshire Avenue Building 66, Room G238
  Silver Spring MD 20993
  301/796-6228
  email: william.jung@fda.hhs.gov
 Michael Mendelson
  FDA/CDRH/ODE
  10903 New Hampshire Avenue Building 66, Room 2548
  Silver Spring MD 20993
  301/796-6280
  email: michael.mendelson@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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