Accuray receives FDA 510(k) clearance for Radixact platform
Accuray received FDA 510(k) clearance for the Radixact Treatment Delivery Platform and integrated software.
Evidence notes
- The FDA clearance covered Radixact Treatment Delivery Platform.
- Accuray Precision treatment planning and iDMS data management were also cleared.
- Accuray planned commercial release in fiscal 2017 Q1.
Company context
Accuray develops and manufactures robotic radiosurgery and image-guided radiation therapy systems, including the CyberKnife and helical TomoTherapy and Radixact platforms.