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U.S. Department of Health and Human Services

Recognized Consensus Standards

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Recognition List Number: 025 FR Publication Date: 10/04/2010 

Part B: Supplementary Information

Recognition Number 12-213: IEC 62220-1-2 Edition 1.0 (2007-06), medical electrical equipment - characteristics of digital x-ray imaging devices - part 1-2: determination of the detective quantum efficiency - detectors used in mammography. (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 X-ray Imaging Devices
Processes Affected:
Premarket and postmarket processes
Type of Standard:
 Vertical, International
Extent of Recognition:
Complete standard
Related CFR Citations and Product Codes:
Regulation
Number
Device Name Device
Class
Product
Code
§892.1715 Full Field Digital,System,X-Ray,Mammographic Class 2 MUE
Relevant Guidance:
Draft Guidance of Industry and FDA Staff: Class II Special Controls Guidance Document: Full Field Digital Mammography System, May 30, 2008
FDA Technical Contact:
 Robert Jennings
  FDA/CDRH/OSEL
  10903 New Hampshire Avenue Building 62, Room 3102
  Silver Spring MD 20993
  301/796-2539
  email: robertj.jennings@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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