FDA 510(k) Applications Submitted by Elekta Limited

FDA 510(k) Number Submission Date Device Name Applicant
K131965 06/27/2013 XVI R5.0 Elekta Limited
K112613 09/07/2011 INTEGRITY(TM) Elekta Limited
K192242 08/19/2019 Synergy Platform, Synergy, Infinity, VersaHD Elekta Limited
K210500 02/22/2021 Elekta Synergy, Elekta Harmony, Elekta Infinity, Versa HD Elekta Limited
K153011 10/14/2015 iViewDose R1.0 Elekta Limited
K182076 08/01/2018 Elekta Unity Elekta Limited
K192482 09/10/2019 Elekta Unity Elekta Limited
K111676 06/15/2011 APEX Elekta Limited


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