Agfa Receives FDA 510(k) Clearance for DR 800 Multi-purpose Digital Imaging System

MORTSEL, Belgium, April 26, 2018 /PRNewswire/ --

• Dynamic MUSICA processes fluoroscopic images with the same high-quality/low-dose features, providing greater diagnostic confidence
• The DR 800 includes a range of features and tools that minimize exam preparation time, procedure time and the wait for images
• X-Team Technology combines viewing and instant communication, supporting a new level of collaboration and multidisciplinary consultation
• Configurable DR 800 combines positioning freedom, workflow improvements and high image quality, for enhanced efficiency and patient satisfaction

Agfa announces today that it has received FDA 510(k) clearance for its DR 800 multi-purpose imaging system. Offering one solution for radiography, fluoroscopy and advanced clinical applications, the DR 800 supports the role of radiology in the value-based care organization with increased versatility, functionality and efficiency.

Dynamic MUSICA for fluoroscopy 
The DR 800 comes standard with Dynamic MUSICA, for both static and dynamic (moving) images. This image processing software also enhances noise suppression, offers excellent brightness control, reduces veiling glare, and plays a significant role in enabling potential dose reduction. MUSICA processes fluoroscopic images with the same high-quality and low-dose features that have made MUSICA essential to radiology departments around the world.  

X-Team Technology workflow enhances collaboration 
This important workflow enrichment integrates the XERO universal viewer -  which provides secure access to images from different departments and sources, in one view - in the MUSICA workstation. Collaboration features, such as instant messaging and clinical dialogue, enhance consultation on study acquisition between radiologists and radiographers.

A single investment for all applications 
The highly versatile, fully integrated DR 800 offers a three-in-one digital imaging solution. This robust solution can handle a full range of radiography (including static exams and tilting exams) and fluoroscopy exams (including barium studies, arthrograms, cystograms, myelography and catheter placement, etc.), without requiring multiple investments.

Maximum versatility, uncompromising imaging 
With its positioning freedom and workflow improvements, the DR 800 enhances both efficiency and patient satisfaction. Its 180 cm SID enables uncompromising chest imaging. The highly customizable DR 800 can be equipped with high-frequency fluoroscopy generator options of 50, 65 or 80 kW, a console for patient-side positioning, a wireless console for remote control, a compressor cone and an auto-switching anti-scatter grid. EasyStitchtm technology enables fast and high precision Full Leg Full Spine exams, while LiveVisiontm technology allows for dose-free remote positioning. Use of Cesium Iodide (CsI) detector technology combined with MUSICA image processing offers high-speed, high-resolution imaging and enables the potential for dose reduction.

"The DR 800 has been designed to enable imaging departments to meet today's growing demand for fluoroscopy, without requiring multiple investments," comments Louis Kuitenbrouwer, Vice President Imaging Division of Agfa. "This versatile solution supports radiology within the care continuum, where informed diagnosis and treatment decisions are important for value-based care. We are very pleased with the FDA 510(k) clearance for its DR 800, which is a real step forward in ensuring radiology has the solutions it needs to handle the challenges of the evolving healthcare model."

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About Agfa 
The Agfa-Gevaert Group is one of the world's leading companies in imaging and information technology. Agfa develops manufactures and markets analogue and digital systems for the printing industry (Agfa Graphics), for the healthcare sector (Agfa HealthCare), and for specific industrial applications (Agfa Materials). Agfa is headquartered in Mortsel, Belgium. The company is present in 40 countries and has agents in another 100 countries around the globe.

George Curley, Director, Marketing Communications, Americas
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SOURCE Agfa HealthCare