IEC ISO 10918-1 First edition 1994-02-15

Standard Organization:

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)]

Recognition Date2014-01-30
Recognition List034
Recognition Number12-261
Extent Complete standard
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STG Radiology
FDA Tech  Stephen Glick   FDA/OMPT/CDRH/OSEL/DIDSR/   301-796-6220   stephen.glick@fda.hhs.gov

Rationale:

This standard is relevant to medical devices and is recognized on its scientific and technical merit and/or because it supports existing regulatory policies.

Scope:

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.

Code of Federal Regulations:

Regulation Number Device Name Device Class Product Code
§892.2050 System, Image Processing, Radiological Class 2 LLZ

FDA Guidance:

Guidance for the Submission of Premarket Notification for Medical Image Management Devices. Document issued on: July 27, 2000


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