Elekta Instrument AB - FDA 510(k) Cleared Devices
Recent clearances: Leksell Vantage Stereotactic System, Leksell Gamma Knife Perfexion, Leksell Gamma Knife Icon, Leksell GammaPlan
35
Total
35
Cleared
0
Denied
FDA 510(k) Regulatory Record - Elekta Instrument AB Neurology ✕
13 devices
Cleared
Aug 01, 2019
Leksell Vantage Stereotactic System
Neurology
119d
Cleared
Sep 15, 2017
Leksell Vantage Stereotactic System
Neurology
151d
Cleared
Mar 02, 2016
Leksell Stereotactic System, Injection/ Aspiration Needle Kit
Neurology
175d
Cleared
May 01, 2009
LEKSELL STEREOTACTIC SYSTEM WITH REUSABLE FIXATION SCREWS
Neurology
445d
Cleared
May 13, 2008
LEKSELL SURGIPLAN, MODEL 1006947
Neurology
103d
Cleared
Jul 23, 2004
ELEKTA MICRODRIVE, MODEL 916716
Neurology
99d
Cleared
Feb 12, 2004
LEKSELL SURGIPLAN WITH IMAGEMERGE
Neurology
118d
Cleared
Dec 06, 2001
MODIFICATION TO LEKSELL SURGIPLAN WITH ATLASPACE
Neurology
15d
Cleared
Sep 24, 1999
LEKSELL IMAGE GUIDANCE SURGICAL SYSTEM, VIEW SCOPE, SURGISCOPE,ELEKTA INSIGHT
Neurology
29d
Cleared
Jul 20, 1999
ELEKTA STEREOTACTIC GUIDE
Neurology
69d
Cleared
Mar 31, 1998
LEKSELL VIEWSCOPE, LEKSELL SURGISCOPE, LEKSELL FREEHAND
Neurology
186d
Cleared
Mar 02, 1998
LEKSELL STEREOTACTIC SYSTEM
Neurology
252d
Cleared
Jul 26, 1996
LEKSELL IMAGE GUIDANCE SURGICAL SYSTEM (LIGS)
Neurology
88d