SUNNYVALE, Calif. - Accuray Incorporated (Nasdaq: ARAY), the premier radiation oncology company, today announced that the U.S. Food and Drug Administration (FDA) has granted the company 510(k) clearance to market the Dose Control System (DCS), a new feature for Accuray's TomoTherapy® System that improves system performance.

The TomoTherapy System revolutionized radiation therapy with the introduction of helical delivery, providing precise application of dose to target structures while sparing healthy tissue. With the advent of the Dose Control System the TomoTherapy System again breaks new ground as the first dose servo-controlled helical delivery system (patent pending). This approach provides even higher precision with unprecedented dose stability throughout complex rotational treatments. Static delivery provided by the TomoDirectTM option also benefits from a more stable and consistent dose rate at every gantry angle.

The new DCS feature provides these gains by automatically adjusting controls previously handled through a manual process. This means small variations in dose rate are immediately corrected by the system, resulting in fewer interruptions. The DCS application also ensures a more stable output over longer duration treatments, such as Total Marrow and Total Body Irradiation. The result of this new product feature is higher customer satisfaction, a better patient experience, and improved overall system performance.
"FDA clearance of the new Dose Control System is a positive step toward improving TomoTherapy System performance and customer satisfaction," said Euan S. Thomson, Ph.D., president and chief executive officer of Accuray. "We are dedicated to offering our customers technological advancements that help streamline their workflow and expand the capabilities of their systems."

With the FDA 510(k) clearance, the DCS application is now available for purchase in the United States. Interested customers can contact their Accuray sales representative or send an email to sales@accuray.com for more information.

About Accuray

Accuray Incorporated (Nasdaq: ARAY), based in Sunnyvale, Calif., is the premier radiation oncology company that develops, manufactures and sells personalized innovative treatment solutions that set the standard of care, with the aim of helping patients live longer, better lives. The Company's leading edge technologies - the CyberKnife and TomoTherapy Systems - are designed to deliver radiosurgery, stereotactic body radiation therapy, intensity modulated radiation therapy, image-guided radiation therapy and adaptive radiation therapy. To date, more than 200,000 patients worldwide have been treated using the Company's technologies and more than 582 systems have been installed in leading hospitals around the world. For more information, please visit www.accuray.com.

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