LITTLETON, Mass.--(BUSINESS WIRE)--May 13, 2005--Breakaway Imaging(TM), LLC, a leading developer of medical imaging systems for surgery, announces receipt of FDA 510(k) pre-market notification for their mobile O-arm(TM) Imaging System. The intended use references 2-D (fluoroscopic) imaging, 3-D (volumetric) imaging, and compatibility with image guided surgery systems.
"This platform has been designed from the ground up for a broad range of surgical applications, with special attention to orthopedic and spine procedures. Many of the procedures we do are three-dimensional in nature. Having on-demand, 3-D intra-operative imaging allows us to see the plane that is most important, the axial plane," comments Hansen Yuan, M.D., Professor of Orthopedics and Neurosurgery at SUNY Syracuse.
