2006-10-30 - 3Dnet FDA Approval


30 October 2006 - London, England.

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
3Dnet™ suite IS a protocol-driven set of tools that enable healthcare professionals to intuitively visualise patient CT, MRI AND PET studies in 3D on a standard Windows-based PC. It can be integrated with a hospital or practice PACS/RIS to provide a seamless experience to the physician or clinician. As 3Dnet Suite does not require any proprietary or specialised hardware to operate, it may be deployed throughout the entire healthcare enterprise for a relative low cost-of-ownership.

About Biotronics 3D
Headquartered IN London, England, Biotronics3D develops and markets innovative software applications for the diagnostic imaging industry. With an objective of transforming the way that healthcare providers interact with 3D images, Biotronics3D provides cutting edge software technologies to improve healthcare by better extracting diagnostic data and transforming it into usable information available at the point-of-care.
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