Varian gets FDA 510(k) clearance for Nexus DR Digital x-ray imaging system

15 September 2016 (Last Updated September 15th, 2016 18:30)

Varian Medical Systems has secured 510(k) approval from the US Food and Drug Administration (FDA) to market the Nexus DR, which is a high-resolution imaging system for x-ray imaging using a digital x-ray detector.

Varian Medical Systems has secured 510(k) approval from the US Food and Drug Administration (FDA) to market the Nexus DR, which is a high-resolution imaging system for x-ray imaging using a digital x-ray detector.

Designed to replace conventional film techniques, or existing digital systems, in multipurpose or dedicated applications, the Nexus DR is a single common imaging platform for general radiographic procedures. However, these producures exclude fluoroscopy, angiography, and mammography.

Varian's imaging components group sales and marketing vice-president Carl LaCasce said: "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.

"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."

Main elements of the Nexus DR include an image detector, a computer, a high resolution monitor, and Varian's proprietary image processing software.

"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."

Each system can be set up to process data from several detectors.

Building on Varian's current line of digital imaging software and workstation products, Nexus DR is designed for installation into new or existing radiographic rooms or for use in mobile x-ray systems.

It complies with the provisions of the European Medical Device Directive (MDD) and will soon be CE Marked.


Image: The Varian Nexus DR. Photo: Varian Medical Systems.