Agfa gets FDA nod for CR mammo unit

Agfa HealthCare has received U.S. Food and Drug Administration (FDA) clearance for its DX-M digitizer with needle-based detectors.

In addition to the needle-based detectors, the computed radiography (CR) mammography package features Agfa's Musica2 image processing software and a five-cassette drop-and-go buffer to provide high throughput, according to the vendor. The reader unit can also be used with general radiography detectors, Agfa said.

DX-M is part of Agfa's digital mammography offering, which includes the company's Impax for Breast Imaging diagnostic workstation and DryStar imagers. The digitizer has also received European Reference Organization for Quality Assured Breast Screening and Diagnostic Services (EUREF) certification. It is available now in the U.S.

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