Elekta has announced 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 included on the Australian Register of Therapeutic Goods (ARTG) for regulatory clearance in Australia in July 2018.
To learn more, visit www.elekta.com/Unity.
Elekta Unity is pending 510(k) pre-market clearance and not available for commercial distribution or sale in the U.S.
This is information that Elekta AB (publ) is obliged to make public pursuant to the EU Market Abuse Regulation. The information was submitted for publication at 15:15 CET on August 7, 2018. (REGMAR)Back To Top
Elekta Unity is pending 510(k) with the FDA for U.S. sales and clinical use clearance. Appl Rad Oncol.