FDA give 510(k) approval for AlluraClarity X Ray Imaging System (Philips)
Philips has received 510(k) clearance from the FDA to market its AlluraClarity Image Guidance X Ray imaging system in the US. The system uses ClarityIQ technology to provide high quality imaging at low X Ray dose levels for patients. ClarityIQ technology will also be available as an upgrade for the majority of Philips' installed base of monoplane and biplane interventional X Ray systems.
According to results from a study carried out at the Karolinska University Hospital in Sweden, the AlluraClarity is able to deliver high image quality with a dose reduction of 73% over conventional imaging systems used in neuroradiology applications. The AlluraClarity was commercially introduced outside the US in mid-2012.
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