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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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