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U.S. Department of Health and Human Services

Recognized Consensus Standards

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Recognition List Number: 019 FR Publication Date: 12/19/2007 

Part B: Supplementary Information

Recognition Number 12-176: IEC 61223-3-2 (2007), evaluation and routine testing in medical imaging departments - part 3-2: acceptance tests - imaging performance of mammographic x-ray equipment. (Radiology)

Date of Standard: 2007. 
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:
ALL OFFICES AND DIVISIONS IN CDRH
Devices Affected:
Digital Mammography
Processes Affected:
510(k), PMA, Device Evaluation, MQSA standards
Type of Standard:
 International, Vertical
Extent of Recognition:
Complete standard
Related CFR Citations and Product Codes:
Regulation
Number
Device Name Device
Class
Product
Code
§892.1715 Full Field Digital,System,X-Ray,Mammographic Class 2 MUE
Relevant Guidance:
Premarket Applications for Digital Mammography System, Policy Guidance Documents under MQSA
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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