Agfa HealthCare's CR digital Mammography Solution with FDA Clearance and EUREF Certification

Agfa HealthCareAgfa HealthCare has received FDA clearance to market its DX-M digitizer with needle-based detectors in the U.S. This next-generation computed radiography (CR) solution is the only CR digital mammography solution today with both FDA clearance and EUREF certification.

Excellent image quality and enhanced detail
The DX-M with needle-based detectors provides excellent image quality with a high Detective Quantum Efficiency (DQE). With its unique five cassette drop-and-go buffer for high throughput, it also supports a smoother workflow.

The DX-M can be used as a centralized or decentralized digitizer in the radiography department, supporting general radiography as well as digital mammography. As the reader unit can also be used with general radiography detectors, the DX-M is ideal for healthcare operations with a tight budget that wish to achieve high image quality in their X-ray imaging. The DX-M comes with Agfa HealthCare's MUSICA2 advanced image processing software for consistently high image quality and enhanced details.

The phosphor needle-based DX-M is a robust system at a reduced total cost of ownership. Furthermore, this allows it to be used in more physically demanding environments, such as mobile mammography screening vans.

Next-generation mammography solution from proven provider
In addition to the FDA clearance, the DX-M has also passed the rigorous physico-technical and clinical tests for EUREF (European Reference Organization for Quality Assured Breast Screening and Diagnostic Services), and received EUREF certification.

"We are pleased and proud that the DX-M is the only CR digital mammography solution to have achieved both FDA clearance and EUREF certification," comments Dirk Debusscher, Vice President Imaging at Agfa HealthCare. "We remain committed to offering the highest standards based on needle detectors in our CR solutions. We already have more than 3000 digital mammography installations around the world, and more than 2000 needle detector-based installations."

Affordable, fully integrated mammography solution
The DX-M is a key part of Agfa HealthCare's digital mammography solution, which also includes the IMPAX for Breast Imaging diagnostic workstation and dedicated DRYSTAR imagers. By crossing imaging and healthcare IT boundaries, it offers a truly fully integrated solution designed for the specific needs of breast imaging departments.

About Agfa
The Agfa-Gevaert Group is one of the world’s leading companies in imaging and information technology. Agfa develops manufactures and markets analogue and digital systems for the printing industry (Agfa Graphics), for the healthcare sector (Agfa HealthCare), and for specific industrial applications (Agfa Materials). Agfa is headquartered in Mortsel, Belgium. The company is present in 40 countries and has agents in another 100 countries around the globe. The Agfa-Gevaert Group achieved a turnover of 2,948 million euro in 2010.

About Agfa HealthCare
Agfa HealthCare, a member of the Agfa-Gevaert Group, is a leading global provider of diagnostic imaging and healthcare IT solutions. The company has nearly a century of healthcare experience and has been a pioneer on the healthcare IT market since the early 1990's. Today Agfa HealthCare designs, develops and delivers state-of-the-art systems for capturing, managing and processing diagnostic images and clinical/administrative information for hospitals and healthcare facilities, as well as contrast media solutions to enable effective medical imaging results. The company has sales offices and agents in over 100 markets worldwide. Sales for Agfa HealthCare in 2010 were 1,180 million euro.