FDA Approval For CR Mammography System

U.S. Shipments of CR Mammography System Underway

ROCHESTER, N.Y., Nov. 18 — Carestream Health has received final approval from the U.S. Food and Drug Administration for its computed radiography system for mammography. The company has begun commercial distribution of this mammography CR system in the U.S.

The CARESTREAM DIRECTVIEW CR Mammography Feature  captures mammography images digitally and can be used in the same clinical applications as traditional screen-film mammography systems. The company has been selling its CR mammography system in Europe, Greater Asia, Japan, Latin America and Canada for several years, and has installed thousands of systems in clinics, breast imaging centers and hospitals of all sizes.

Carestream Health’s CR mammography system received PreMarket Approval under the FDA’s rigorous Class III standards. These are the FDA's most stringent requirements and require extensive scientific and regulatory evidence that the device is safe and effective before it can be placed on the market.

The FDA has reclassified new FFDM systems under Class II controls, which require only that the product be substantially equivalent to a currently marketed device. This reclassification will allow Carestream Health to more rapidly bring new enhancements to the radiology market.

Carestream Health’s mammography option is available when purchasing a new CARESTREAM CR system, or as an upgrade to installed models—and can be used for both general radiography and mammography exams.
The company offers a digital portfolio of women’s healthcare solutions that includes: digitizing systems for converting film images for softcopy comparison; mammography modules for its RIS/PACS platform; a multi-modality breast imaging workstation that allows reading of all breast imaging modalities as well as general radiology exams; CAD solutions; and high-resolution output to DRYVIEW Laser Imaging Systems. For more information, please visit http://mammo.carestreamhealth.com 


About Carestream Health
Carestream Health is a worldwide provider of dental and medical imaging systems and healthcare IT solutions; molecular imaging systems for the life science research and drug discovery/development market segments; and x-ray film and digital x-ray products for the non-destructive testing market. For more information about the company’s broad portfolio of products, solutions and services, please contact your Carestream Health representative or visit www.carestreamhealth.com.
CARESTREAM and DIRECTVIEW are trademarks of Carestream Health.