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Updated: July 8th, 2008 05:26 PM CDT

Kodak Submits Digital Imaging System for Mammography to FDA

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Business Wire
via NewsEdge Corporation

ROCHESTER, N.Y.--(BUSINESS WIRE)--Nov. 17, 2005--Eastman Kodak Company announced it has begun the process for obtaining U.S. Food & Drug Administration (FDA) approval to market a digital medical imaging system for mammography in the United States.

Following required regulatory procedures, Kodak submitted information to the FDA on the manufacturing of its computed radiography (CR) system for mammography and on analytical tests the system has undergone.

The filings are part of Kodak's plan for enhancing its current CR systems--which are increasingly used as an alternative to conventional x-ray film--with a special feature intended to offer the ability to produce mammography images. This goal of this feature is to offer sharp and detailed images required for mammography. Additionally, CR systems can process medical images in minutes, speeding results to physicians and patients. The systems also enable medical facilities to better manage patient workloads, thus enabling greater operational efficiency and shorter wait times for patients.

Kodak currently is conducting clinical trials of its digital mammography system at several sites in the U.S. and Canada, which are required for obtaining regulatory approval in both countries.

Hundreds of medical institutions outside the U.S. and Canada already have installed KODAK DIRECTVIEW CR 850, CR 950 and CR 975 Systems with the innovative mammography feature. This optional feature became available in Europe, Greater Asia, Japan and Latin America earlier this year.

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