CR Digital Mammography System First to Have Both FDA Clearance and EUREF Certification

A new computed radiography (CR) mammography digitizer that offers consistent, very high image quality is now available in the US market.

Agfa HealthCare (Mortsel, Belgium) announced that it has received FDA clearance to market its DX-M digitizer with needle-based detectors in the United States. This next-generation CR solution is the only CR digital mammography solution with both US Food and Drug Administration (FDA) clearance and EUREF (European Reference Organization for Quality Assured Breast Screening and Diagnostic Services) certification.


The DX-M with needle-based detectors provides excellent image quality with high detective quantum efficiency (DQE). With its novel 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 suitable 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. In addition to the FDA clearance, the DX-M has also passed the rigorous physicotechnical and clinical tests for EUREF, 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,” commented 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 3,000 digital mammography installations around the world, and more than 2,000 needle detector-based installations.”

The DX-M is a major part of Agfa HealthCare’s digital mammography solution, which also includes the Impax for Breast Imaging diagnostic workstation and Drystar imagers. By crossing imaging and healthcare information technology (IT) boundaries, it offers a fully integrated system designed for the specific needs of breast imaging departments.

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