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U.S. Department of Health and Human Services

Recognized Consensus Standards: Medical Devices

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Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 034 Date of Entry 01/30/2014 
FR Recognition Number 12-261
ISO IEC  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)]
This CCnT Recommendation I International Standard is applicable to continuous-tone - grayscale or colour - digital still image data. It is applicable to a wide range of applications which require use of compressed images. It is not applicable to bi-Ievel image data.

This Specification

- specifies processes for converting source image data to compressed image data;

- specifies processes for converting compressed image data to reconstructed image data;

- gives guidance on how to implement these processes in practice;

- specifies coded representations for compressed image data.
Extent of Recognition
Complete standard
Rationale for Recognition
This standard is relevant to medical devices and is recognized on its scientific and technical merit and/or because it supports existing regulatory policies.
Public Law, CFR Citation(s) and Procode(s)*
Regulation Number Device Name Device Class Product Code
§892.2050 System, Image Processing, Radiological Class 2 LLZ
Relevant FDA Guidance and/or Supportive Publications*
Guidance for the Submission of Premarket Notification for Medical Image Management Devices. Document issued on: July 27, 2000

Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices - Guidance for Industry and Food and Drug Administration Staff, issued September 2018.
FDA Technical Contact
 Stephen Glick
Standards Development Organizations
ISO International Organization for Standardization https://www.iso.org/
IEC International Electrotechnical Commission http://www.iec.ch/
FDA Specialty Task Group (STG)
*These are provided as examples and others may be applicable.