February 21, 2019 — Agfa Healthcare has received U.S. Food and Drug Administration (FDA) 510(k) clearance for its DR 800 multipurpose digital radiography (DR) 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 2-D single-plane imaging to multi-slice image reconstruction. Tomosynthesis is used to synthesize tomographic slices from a single tomographic sweep.
The DR 800 includes Agfa’s brand-new tomosynthesis algorithms for iterative reconstruction, which deliver images with less noise and fewer artifacts. These algorithms also enable very fast image reconstruction in less than one minute, overcoming the usual slow iterative reconstruction process.
The system comes standard with Dynamic MUSICA, for both static and dynamic images. This image processing software enhances noise suppression, offers superb brightness control, reduces veiling glare, and plays a significant role in enabling potential dose reduction.
Dynamic MUSICA 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 fully integrated DR 800 offers a multipurpose digital imaging solution that can handle a full range of radiography (including static exams and tilting exams) and fluoroscopy exams (including barium meals, swallows and enemas, arthrograms and cystourethrograms, myelography and catheter placement, etc.), as well as tomosynthesis exams.
The DR 800 is not available in Canada.
For more information: www.agfahealthcare.com
December 10, 2025 
