FDA gives 510(K) approval for Leksell Gamma Knife Icon radiosurgery system- Elekta

Elekta’s Leksell Gamma Knife Icon radiosurgery system has received 510(k) clearance from the FDA. Gamma Knife Icon represents the sixth generation of the company’s Leksell Gamma Knife system, a technology that has been in use worldwide and continually evolving since the 1980s.

Gamma Knife radiosurgery is a gentler alternative to traditional brain surgery for health problems such as metastatic disease. The system delivers up to thousands of low-intensity radiation beams to one or more targets in a single session. Integrated in Gamma Knife Icon are novel online Adaptive DoseControl and high-definition motion management technologies that assure accuracy for all treatments, as well as an efficient workflow.