Elekta Limited - FDA 510(k) Cleared Devices

Cleared Jun 11, 2021

Elekta Synergy, Elekta Harmony, Elekta Infinity, Versa HD

K210500 · IYE

Radiology · 109d

Cleared Dec 05, 2019

Elekta Unity

K192482 · IYE

Radiology · 86d

Cleared Nov 22, 2019

Synergy Platform, Synergy, Infinity, VersaHD

K192242 · IYE

Radiology · 95d

Cleared Dec 04, 2018

Elekta Unity

K182076 · IYE

Radiology · 125d

Cleared Dec 11, 2015

iViewDose R1.0

K153011 · IYE

Radiology · 58d

Cleared Sep 25, 2013

XVI R5.0

K131965 · IYE

Radiology · 90d

Cleared Dec 16, 2011

INTEGRITY(TM)

K112613 · IYE

Radiology · 100d

Cleared Sep 30, 2011

APEX

K111676 · IXI

Radiology · 107d