10 January 2007 - London, England.
3Dnet Suite Receives CE Mark and EN ISO:13485:2003
Biotronics3D today announced that it has received both CE Mark MDD Class IIa and EN ISO:13485:2003 certifications, important for marketing its software 3Dnet Suite within the European Union. “These certifications are significant milestones for Biotronics3D. Not only do they identify that we fulfill all the appropriate medical device directives for the EU and ISO, they also show Biotronics3D's continued commitment TO providing quality technology," said Dr Haralambos Hatzakis, CEO of Biotronics3D.
About 3Dnet Suite
The product suite, a protocol-driven set of tools that enable healthcare professionals to intuitively visualize patient CT, MRI and PET studies in 3D on a standard Windows-based PC, received FDA 510(k) clearance in October. 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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