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U.S. Department of Health and Human Services

Recognized Consensus Standards

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FR Publication Date: 01/30/2014 

Part B: Supplementary Information

NEMA PS 3.1 - 3.18 (2008), digital imaging and communications in medicine (dicom) set. (Radiology)
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:
OFFICE OF IN VITRO DIAGNOSTICS AND RADIOLOGICAL HEALTH (OIR)
Devices Affected:
Picture Archiving and Communications, Telemedicine Systems
Processes Affected:
510(k)
Type of Standard:
 National, Horizontal
Extent of Recognition:
Complete standard and any annexes
Related CFR Citations and Product Codes:
Regulation
Number
Device Name Device
Class
Product
Code
§892.2050 System, Image Processing, Radiological Class 2 LLZ
Relevant Guidance:
Guidance for Industry
Guidance for the Submission of Premarket Notifications for Medical Image Management Devices. Document issued on: July 27, 2000
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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