Fuji mammo CR gets FDA nod

AuntMinnie.com staff writers

May 30, 2006

Fujifilm Medical Systems USA has received an approvable letter from the U.S. Food and Drug Administration for its computed radiography for mammography (FCRm) device. Fuji hopes to become the first vendor to sell a CR-based digital mammography system in the U.S.

The letter indicates that the FDA has completed its review of the company's premarket approval (PMA) application and that the PMA is approvable, according to the Stamford, CT-based firm.

The product enables sites to conduct digital mammography with an existing analog mammography acquisition unit by adding a CR cassette to the system. It provides both an 18 x 24-cm and 24 x 30-cm field-of-view, 50-micron pixel sampling, and the company's proprietary dual-side reading technology, Fuji said.

The FCRm is already available in Europe, Asia, and Canada.

By AuntMinnie.com staff writers
May 31, 2006

Related Reading

Fuji nets Novation deal, May 9, 2006

Orthocrat, Fuji sign agreement, March 21, 2006

Fuji provides CR for horse show, March 17, 2006

Fuji gets CR mammo approval in Canada, February 21, 2006

Fuji completes PACAF deployment, February 9, 2006

Copyright © 2006 AuntMinnie.com

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