Elekta Limited - FDA 510(k) Cleared Devices
Recent clearances: Elekta Synergy, Elekta Harmony, Elekta Infinity, Versa HD, Elekta Unity, Synergy Platform, Synergy, Infinity, VersaHD
8
Total
8
Cleared
0
Denied
FDA 510(k) Regulatory Record - Elekta Limited Radiology ✕
8 devices
Cleared
Jun 11, 2021
Elekta Synergy, Elekta Harmony, Elekta Infinity, Versa HD
Radiology
109d
Cleared
Dec 05, 2019
Elekta Unity
Radiology
86d
Cleared
Nov 22, 2019
Synergy Platform, Synergy, Infinity, VersaHD
Radiology
95d
Cleared
Dec 04, 2018
Elekta Unity
Radiology
125d
Cleared
Dec 11, 2015
iViewDose R1.0
Radiology
58d
Cleared
Sep 25, 2013
XVI R5.0
Radiology
90d
Cleared
Dec 16, 2011
INTEGRITY(TM)
Radiology
100d
Cleared
Sep 30, 2011
APEX
Radiology
107d