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

Friday, April 27, 2018

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. EasyStitch™ technology enables fast and high precision Full Leg Full Spine exams, while LiveVision™ 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."