Kodak starts FDA process for CR mammo

AuntMinnie.com staff writers
Nov 16, 2005

Eastman Kodak Health Group has begun the submission process to the Food and Drug Administration for approval to apply its computed radiography (CR) technology to mammography applications.

The filings are part of Kodak's plan for obtaining U.S. and Canadian regulatory approval for the DirectView CR mammography feature on its CR 850, CR 950, and CR 975 systems, according to the Rochester, NY-based vendor.

The first modules will contain manufacturing and nonclinical information, Kodak said. The firm is currently conducting clinical trials of CR mammography at several sites in the U.S. and Canada.

By AuntMinnie.com staff writers
November 17, 2005

Related Reading

Road to RSNA, Eastman Kodak Health Group, November 14, 2005

Road to RSNA, Eastman Kodak Health Group, November 11, 2005

Canadian hospital purchases Kodak PACS, CR, and DR, November 9, 2005

Road to RSNA, Eastman Kodak Health Group, November 8, 2005

Kodak inks Spectrum deal, October 26, 2005

Copyright © 2005 AuntMinnie.com

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