FDA Approval Of Advanced Software, Screens For CR Mammography

 ROCHESTER, N.Y., Dec. 9 — Carestream Health announced the U.S. Food and Drug Administration (FDA) has approved a Premarket Approval (PMA) supplement for enhanced screens and image processing software for its CR mammography system. 

Carestream Health’s EHR-M3 screens are its third generation of screens designed specifically for mammography. The system has higher DQE (detective quantum efficiency) with the new screens, which were designed to enhance the quality of the acquired images.  The latest approval also covers the application of Carestream Health’s advanced image processing algorithm that was designed to enhance the overall displayed quality of mammography images.

These features were released in other markets around the world earlier this year, and the latest approvals allow these advanced features to be immediately implemented in clinics, breast imaging centers and hospitals in the United States.

The optional CARESTREAM DIRECTVIEW CR Mammography Feature allows users of the company’s Classic, Elite, CR 850, CR 950 and CR Max systems to perform high-resolution mammograms in addition to general radiography exams. These CR-based mammography systems are part of a full range of digital mammography solutions from Carestream Health, including mammography RIS/PACS; CAD for its CR systems; and high-resolution output to DRYVIEW Laser Imaging Systems.


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 is a trademark of Carestream Health.