FDA Clears Opko’s Imaging System
January 23, 2009
Opko Health has received FDA 510(k) for its Spectral OCT SLO combination imaging system. The diagnostic device helps detect and manage ocular diseases affecting the posterior segment of the eye. It can be used to view, image and measure posterior ocular structures such as the retina, macula, retina nerve fiber layer and optic disk. It also can image the cornea, sclera and conjunctiva by changing the focal position, Opko said.