Agfa announces today that it has received FDA 510(k) clearance for its DR 800* multipurpose imaging system with tomosynthesis. Offering one solution for radiography, fluoroscopy, multi-slice and advanced clinical applications, the DR 800 supports the role of radiology in the value-based care organization with increased versatility, functionality and efficiency.
With the DR 800, Agfa moves from 2D single plane imaging to multi-slice image reconstruction. Tomosynthesis is used to synthesize tomographic slices from a single tomographic sweep.
DR 800 comes standard with Dynamic MUSICA that includes MUSICA Digital TomoSynthesis software, which powers the tomosynthesis reconstruction, automatically presenting images with optimal contrast, and providing consistent image quality across the individual slices and images.
“The DR 800 has already been supporting imaging departments to meet today’s growing demand for versatility, without requiring multiple investments,” comments Louis Kuitenbrouwer, Vice President Imaging Division of Agfa. “With the FDA 510(k) clearance for tomosynthesis, the DR 800 supports best-in-class multi-slice imaging, using algorithms that reconstruct images very quickly.”
Read the full press release here
*DR 800 is not yet available in Canada.