Elekta Unity is pending 510(k) with the FDA for U.S. sales and clinical use clearance
STOCKHOLM, August 7, 2018 – Elekta (EKTA-B.ST) announced today that it submitted a 510(k) application for its Elekta Unity magnetic resonance radiation therapy (MR/RT) system to the U.S. FDA, where the submission is in the review process. Upon receiving FDA 510(k) pre-market clearance, U.S. healthcare providers will then be able to offer Unity’s distinctive real time imaging, planning, and treatment technology to their patients. Elekta Unity, which combines high-field 1.5 Tesla MR imaging, precision radiation therapy and intelligent software, received CE mark in June 2018 and was