Guerbet announced today via press release that its OptiOne Single-Head Contrast Delivery System has received 510(k) clearance from the FDA.
The delivery system, which combines multi-purpose functionality with ease-of-use, is designed to inject patients with contrast agents for the purposes of obtaining diagnostic images through CT scans, the company said.
"We are extremely pleased to announce the availability of this newest injector system, as we believe that it offers additional flexibility to our customers, while providing the innovative features technologists have come to expect from Guerbet," said Massimo Carrara, the company’s U.S. general manager. "The U.S. approval for OptiOne builds upon Guerbet's commitment to be a global leader specializing in contrast media and imaging solutions and services."
Already available in European markets since 2005, FDA clearance of the OptiOne delivery system reinforces Guerbet’s international focus on imaging innovation to better serve its customers, the company said.
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