Medical Device Manufacturer · US , Lake Forest , CA

Elekta Instrument AB - FDA 510(k) Cleared Devices

35 submissions · 35 cleared · Since 1996

35

Total

35

Cleared

0

Denied

FDA 510(k) cleared devices by Elekta Instrument AB Radiology ✕

22 devices

1-12 of 22

Cleared Mar 30, 2018

Leksell Gamma Knife Perfexion, Leksell Gamma Knife Icon

Radiology · 106d

Cleared Feb 09, 2018

Leksell GammaPlan

Radiology · 57d

Cleared Apr 20, 2016

Leksell Gamma Knife Icon

Radiology · 63d

Cleared Oct 29, 2015

Leksell Gamma Knife Perfexion

Radiology · 181d

Cleared Sep 03, 2015

Leksell GammaPlan

Radiology · 76d

Cleared Aug 04, 2015

Leksell Gamma Knife Icon

Radiology · 55d

Cleared May 09, 2014

LEKSELL GAMMA KNIFE PERFEXION

Radiology · 170d

Cleared May 24, 2012

LEKSELL GAMMA KNIFE PERFEXION

Radiology · 69d

Cleared Dec 21, 2010

LEKSELL GAMMAPLAN

Radiology · 63d

Cleared Sep 22, 2009

EXTEND FRAME SYSTEM, MODEL 1009633

Radiology · 75d

Cleared Jul 20, 2009

LEKSELL GAMMAPLAN

Radiology · 105d

Cleared Mar 05, 2007

LEKSELL GAMMA KNIFE PERFEXION

Radiology · 105d