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www.fdanews.com/articles/107796-medrad-infusion-system-cleared

Medrad Infusion System Cleared

June 18, 2008

Medrad’s 510(k) for its Fluorodeoxyglucose (FDG) infusion system for positron emission tomography (PET) and computed tomography (CT) imaging procedures has been cleared by the FDA.

The system automatically extracts a patient dose from a multidose vial and delivers it directly to the patient, allowing for minimal manual dose preparation, handling and radiation exposure to the technologist, the company said.

Real-time dose availability information, an integrated ionization chamber and an optional weight-based dose calculation enable the healthcare provider to more precisely customize each patient's dose.