Contrast agent manufacturer Guerbet has received U.S. Food and Drug Administration (FDA) 510(k) clearance for its OptiOne single-head CT contrast delivery system.
An entry-level, single-head injector, OptiOne debuted in Europe in 2015 and is available in ceiling-suspended and pedestal configurations, according to the firm. It includes a programmable powerhead and can accommodate prefilled or empty syringes, Guerbet said.
OptiOne is manufactured by Liebel-Flarsheim, which was acquired by Guerbet as part of its acquisition of Mallinckrodt's Contrast Media and Delivery Systems business in November.
