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U.S. Department of Health and Human Services

Recognized Consensus Standards

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Recognition List Number: 020 FR Publication Date: 09/09/2008 

Part B: Supplementary Information

Recognition Number 12-166: NEMA XR 23-2006, "quality control manual" template for manufacturers of hardcopy output devices labeled for final interpretation in full-field digital mammography. (Radiology)

Date of Standard: 2006. 
Address of Standards Development Organization:
 National Electrical Manufacturers Association (NEMA)
  1300 North 17th Street
  Suite 1847
  Rosslyn, VA 22209
 
CDRH Office and Division associated with recognized standards:
ALL OFFICES AND DIVISIONS IN CDRH
Devices Affected:
Full Field Digital Mammography Display
Processes Affected:
510(k), PMA, MQSA
Type of Standard:
 National, 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
§892.2050 System, Image Processing, Radiological Class 2 LLZ
Relevant Guidance:
Guidance for Industry
Guidance for the Submission of Premarktet Notifications for Medical Image Management Devices. Document issued on: July 27, 2000

Premarket Applications for Digital Mammography Systems; Final Guidance for Industry and FDA. Document issued on February 16, 2001
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
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