Industry Press Releases

Agfa Receives FDA 510(k) Clearance for DR 800 With Tomosynthesis

Friday, Feb 22, 2019

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.

The DR 800 includes Agfa's brand-new, tomosynthesis algorithms for iterative reconstruction, which deliver images with less noise and fewer artefacts. These algorithms also enable very fast image reconstruction, in less than one minute, overcoming the usual slow iterative reconstruction process.

Dynamic MUSICA

The DR 800 comes standard with Dynamic MUSICA, for both static and dynamic (moving) 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.

Maximum versatility, uncompromising imaging

The highly versatile, fully integrated DR 800 offers a multi-purpose digital imaging solution. This robust and reliable solution can handle a full range of radiography (including static exams and tilting exams), fluoroscopy exams (including barium meals, swallows and enemas, arthrograms and cysto-urethrograms, myelography and catheter placement, etc.), as well as tomosynthesis exams.

"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."

*DR 800 is not available in Canada

About Agfa

Agfa NV is one of the world's leading companies in imaging technology. Agfa NV develops, manufactures and markets analogue and digital systems for the printing industry, for the healthcare sector, and for specific industrial applications.  The group has more than 150 years of imaging experience.  The healthcare division delivers diagnostic imaging solutions that set standards in productivity, safety, clinical value and cost effectiveness.  Agfa is headquartered in Mortsel, Belgium. The company is present in 40 countries and has agents in another 100 countries around the globe.

 

Source: prnewswire.com

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