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2006-10-30 - 3Dnet FDA Approval
Biotronics3D's 3Dnet Suite Receives FDA 510(k) Approval Biotronics3D today announced that it has received 510(k) approval from the US Food and Drug Administration FOR the use OF its advanced 3D medical visualisation software 3Dnet Suite in radiological applications. The approval permits the company to market the 3Dnet Suite product line to the United States where the company has plans of a formal US product launchnext month at the Radiological Society OF North America’s (RSNA) annual conference in Chicago. Dr Haralambos Hatzakis, CEO of Biotronics3D said, “The process for obtaining FDA approval is both arduous and lengthy so with RSNA right around the corner, the timing couldn’t be better. We are inordinately pleased to be able to exhibit AT the conference with the 510(k) approval because it shows the attendees just how comitted we are to the American market and it will provide Biotronics3D with opportunities that we would not have been able to pursue otherwise.” About 3Dnet Suite About Biotronics 3D |