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FDA approves distribution of Agfa's DR 800 with tomosynthesis

by John R. Fischer, Senior Reporter | February 28, 2019
Agfa's DR 800
The FDA has given Agfa the stamp of approval to begin distribution of the latest version of its DR 800 system – now featuring tomosynthesis.

The design of the multipurpose imager is expected to equip providers with one solution for radiography, fluoroscopy, multi-slice and advanced clinical applications, and extends Agfa’s capabilities from 2D single-plane imaging to include the use of tomosynthesis for synthesizing multi-slice imaging reconstruction from a single tomographic sweep.

"The DR 800 has already been supporting imaging departments to meet today's growing demand for versatility, without requiring multiple investments," said Louis Kuitenbrouwer, Vice President Imaging Division of Agfa, in a statement. "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."

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Providing iterative reconstruction, the algorithms enable image delivery with less noise and fewer artifacts, and help overcome the typical slow pace of the process by reconstructing images in less than one minute.

In addition to tomosynthesis, it can manage a full range of radiography exams, including static and tilting procedures, and fluoroscopy, including barium meals, swallows and enemas, arthrograms and cysto-urethrograms, myelography and catheter placement.

Static and dynamic image production are both supported with Dynamic MUSICA, an image processing software that enhances noise suppression, offers high-quality brightness control, reduces veiling glare and aids in potential dose reduction.

The release of the system builds on the progress and capabilities offered by the previous DR 800 version which received FDA clearance in April 2018 and was on display this past November at RSNA in Chicago.

The system is not yet available in Canada.

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