Elekta Receives U.S. FDA 510(k) Clearance Following Launch Of New Versa HD Radiation Therapy System For Cancer Treatment
ATLANTA, April 11, 2013 /PRNewswire/ -- Elekta recently received 510(k) clearance from the U.S. Food and Drug Administration (FDA), allowing the company to begin shipping and installation of all components of the Versa HD™ system within the United States. Featuring high precision beam shaping and tumor targeting, and capable of delivering radiation doses three times faster than previous Elekta linear accelerators, Versa HD sets a higher benchmark for cancer treatment.
"We are delighted to receive FDA clearance," says Jay Hoey, Executive Vice President, Elekta North America. "The potential clinical benefits for patients are significant. Further, the operational benefits for clinicians and providers are eagerly anticipated."
Uniting high dose rate delivery with rapid MLC leaf speedFully integrated with the Agility™ 160-leaf multileaf collimator (MLC), Versa HD provides high-definition, high-speed beam shaping over a versatile 40 X 40 cm field. This unique combination of fast MLC leaf speed with the new High Dose Rate mode empowers clinicians to fully exploit high dose rate delivery and take advanced therapies such as VMAT, SRS and SRT to new levels – without compromising treatment times.
Versa HD also features:
- Industry-leading safety innovations
- Customizable, disease-specific configurations
- Modern patient-friendly ergonomics
- Fewer delays and downtime with real-time remote system monitoring
- Low environmental impact, low energy consumption design
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