Elekta Instrument AB - FDA 510(k) Cleared Devices
35
Total
35
Cleared
0
Denied
FDA 510(k) cleared devices by Elekta Instrument AB Radiology ✕
22 devices
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
Cleared
Aug 21, 2006
LEKSELL GAMMA KNIFE PERFEXION, MODEL 715000
Radiology
42d
Cleared
Jul 05, 2006
LEKSELL GAMMAPLAN
Radiology
30d
Cleared
Jul 25, 2005
ELEKTA ESARTE FRAME SYSTEM
Radiology
26d
Cleared
Jun 01, 2005
GAMMAPLAN
Radiology
40d
Cleared
Sep 08, 2004
LEKSELL GAMMAPLAN 4C WITH MULTIVIEW
Radiology
16d
Cleared
Jul 25, 2003
MODIFICATION TO LEKSELL STEREOTACTIC SYSTEM
Radiology
29d
Cleared
Jul 25, 2003
ELEKTA LEKSELL STEREOTACTIC SYSTEM WITH MR POST KIT
Radiology
28d
Cleared
May 21, 1999
LEKSELL GAMMA KNIFE TARGET SYSTEM, MODEL 24001
Radiology
169d
Cleared
Apr 24, 1997
ACCESSORIES TO THE STEREOTACTIC BODY FRAM
Radiology
90d
Cleared
Apr 23, 1996
STEREOTACTIC BODY FRAME
Radiology
90d