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Accuray Receives FDA 510(k) Clearance For New CyberKnife® M6™ Series, Merging Multileaf Collimation With Non-Isocentric Robotic Delivery

SUNNYVALE, Calif., Nov. 1, 2012 /PRNewswire/ --  Accuray Incorporated (Nasdaq: ARAY), the premier radiation oncology company, today announced that the company received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its new CyberKnife ® M6 Series. The CyberKnife M6 Series features expanded clinical capabilities, reduced treatment times and an enhanced patient experience. The new CyberKnife M6 FIM and FM Systems, featuring the InCise™ Multileaf Collimator combines the benefits of beam shaping with the flexibility of non-isocentric, non-coplanar delivery offering unmatched clinical capabilities and expanding the number of patients eligible for treatment.

The new InCise Multileaf Collimator was designed specifically for stereotactic radiosurgery (SRS) and stereotactic body radiation therapy (SBRT) treatments, giving the system the capability to extend its radiosurgical accuracy into a broader field of applications, meeting radiosurgery and radiotherapy needs. With the InCise Multileaf Collimator, the CyberKnife M6 Series can be used to treat large and irregular tumors more efficiently with excellent dose gradients. This added flexibility expands the number of patients eligible for treatment with the CyberKnife M6 Series.

"The CyberKnife M6 Series offers a collimation option to address a variety of clinical applications, including large, complex tumors. The InCise Multileaf Collimator is designed to sculpt a single radiation beam to match the exact contour of a tumor, which would significantly minimize the amount of radiation to the surrounding tissues and reduce the treatment time," said Dwight Heron, M.D., Professor and Vice-Chairman, Radiation Oncology, Otolaryngology, Head & Neck Surgery at the University of Pittsburgh School of Medicine. "Now many targets previously unsuited for SRS/SBRT can be treated more quickly and effectively than before."

Unlike any other MLC on the market, the InCise Multileaf Collimator can not only move its leaves to create complex shapes, it can also be moved around the patient by a robot in 3D to deliver precisely shaped beams to the target from hundreds of unique angles. This non-isocentric, non-coplanar delivery enables the highest level of accuracy and healthy tissue sparing. The added flexibility is further enhanced when combined with the CyberKnife's Synchrony® System, which enables the CyberKnife M6 System to track tumors as they move and automatically correct for their movement throughout treatment.

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