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Accuray Submits 510(k) Premarket Notification to FDA for Its Radixact™ Treatment Delivery System

ARAY, -1.83% announced today the submission of its 510(k) premarket notification with the Food and Drug Administration (FDA) for the company's Radixact™ Treatment Delivery System. Accuray also submitted 510(k) premarket notification for its treatment planning and data management systems, Precision™ Treatment Planning System and iDMS™ Data Management System.

The treatment delivery system, Precision Treatment Planning System, and iDMS Data Management System have been designed to seamlessly work together and improve treatment workflow processes. Multiple Radixact Systems may use a single, centralized database for treatment planning and patient data management.

"The Radixact System is the next generation TomoTherapy [®] platform and is being designed to leverage its unique architecture, providing a mainstream option for more clinicians. The new platform, comprised of the treatment delivery, treatment planning and data management systems, is expected to expand clinical capabilities while significantly increasing the ease and speed with which clinicians can provide precise radiation treatments," said Joshua H. Levine, president and chief executive officer of Accuray. "The Radixact System will provide the foundation for continued innovation in the months and years ahead. Working with clinicians we will continue the development of clinically relevant, leading-edge technologies with the potential to truly change the radiation therapy treatment experience."

The next generation platform is designed for increased throughput, higher reliability and ease of serviceability. The ring gantry-based delivery system will offer the same proven...