Varian Medical Systems (VAR) Nexus DR Digital X-Ray Imaging System Gains FDA 510(k) Clearance
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Varian Medical Systems (NYSE: VAR) today announced it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market the Nexus DR, a high resolution imaging system for X-ray imaging using a digital X-ray detector. The Nexus DR is designed to replace conventional film techniques, or existing digital systems, in multipurpose or dedicated applications. The system is a single common imaging platform intended for general radiographic procedures (excluding fluoroscopy, angiography, and mammography).
"Nexus DR enables an operator to acquire, display, process, transmit, export images to portable media and send images over a network for long term storage," said Carl LaCasce vice president sales & marketing for Varian's Imaging Components group. "The advanced image processing algorithms in the Nexus DR make it possible to bring out diagnostic details that can be difficult to see using conventional imaging techniques."
The major components of the Nexus DR include an image detector, a computer, a high resolution monitor, and Varian's proprietary image processing software. Each system can be set up to process data from multiple detectors.
Nexus DR builds on Varian's current line of digital imaging software and workstation products, designed for installation into new or existing radiographic rooms or for use in mobile X-ray systems. It complies fully with the provisions of the European Medical Device Directive (MDD) and will soon be CE Marked.
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