Guerbet Receives FDA 510(k) Clearance

Guerbet has scooped up 510(k) clearance from the FDA for its OptiOne single-head contrast delivery system, featuring advanced multi-purpose functionality for CT imaging procedures.

The product is an entry-level single-head injector launched last year in Europe, 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. — Jonathon Shacat