Guerbet announced that it has received 510K clearance from the US Food and Drug Agency (FDA) for its OptiOne™ Single-Head Contrast Delivery System, featuring advanced multi-purpose functionality for CT imaging procedures.
The US clearance confirms Guerbet's international focus in providing innovative imaging solutions to serve wider customer needs. The OptiOne is an entry-level single-head injector launched in 2015 on the European market, available in ceiling-suspended and pedestal form. It is designed for the injection of radiopaque contrast agents in the vascular system of patients to obtain diagnostic images in CT scan examinations. Guerbet will present the injector at the upcoming European Congress of Radiology (ECR, Vienna, 2-6 march 2016).
The OptiOne Single-Head Contrast Delivery System combines ease of use, multi-purpose functionality and optimized contrast media usage. It is designed to be adaptable to the workflow of the imaging department, providing a fully programmable powerhead with intuitive bedside operation and flexibility of use with the ability to accommodate prefilled or empty syringes. The OptiOne is intended for use by doctors, radiology technologists and other licensed medical practitio.
