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U.S. Department of Health and Human Services

Recognized Consensus Standards

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Recognition List Number: 034 FR Publication Date: 01/30/2014 

Part B: Supplementary Information

Recognition Number 12-261: IEC / ISO 10918-1 First edition 1994-02-15, information technology - digital compression and coding of continuous-tone still images: requirements and guidelines [including: technical corrigendum 1 (2005)]. (Radiology)

Date of Standard: 1994. 
Addresses of Standards Development Organizations:
 International Electrotechnical Commission (IEC)
  3, Rue de Varembe'
  PO Box 131
  CH-1211 Geneva 20, 0
  SWITZERLAND
 International Organization for Standardization (ISO)*
  1, Rue de Varembe
  Case Postale 56
  CH 1211 Geneva 20, 0
  SWITZERLAND
CDRH Office and Division associated with recognized standards:
OFFICE OF DEVICE EVALUATION (ODE)
Devices Affected:
Medical Image Management Devices, Telemedicine Systems, Image Storage Systems
Processes Affected:
510(k)
Type of Standard:
 Horizontal, International
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 the Submission of Premarket Notification 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
* 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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