Xoran files for FDA 510(k)
by Katie Pfaff
Point of care low-dose radiation and cone-beam CT system firm, Xoran Technologies, has submitted an FDA 510(k) application for its open-bore fluoroscopy computed tomography (CT). The technology, called TRON, offers point-of-care imaging for the entire body.
The technology, if approved, would offer better accessibility to CT in smaller spaces, lower risk to patients from transport, and better efficiency in radiology. The mobile technology adds accessibility to the CT technology.
"This addition solidifies our commitment to improving patient accessibility to imaging at the point of care,” said Misha Rakic, chief executive officer of Xoran. “The benefits of truly mobile compact devices cannot be underscored, and now by engineering the success of our head CT systems into an open-bore system, we are able to drive a new generation of Xoran's point-of-care (POC) imaging devices.”
The FDA 510(k) submission would add to Xoran’s technology suite and add to the company’s R&D in CT. The technology can be used in point-of-care CT in the operating room, satellite use, and neuro intensive care unit.
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