Elekta Instrument AB - FDA 510(k) Cleared Devices
35
Total
35
Cleared
0
Denied
35 devices
Cleared
Jul 25, 2003
ELEKTA LEKSELL STEREOTACTIC SYSTEM WITH MR POST KIT
Radiology
28d
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
May 21, 1999
LEKSELL GAMMA KNIFE TARGET SYSTEM, MODEL 24001
Radiology
169d
Cleared
Mar 31, 1998
LEKSELL VIEWSCOPE, LEKSELL SURGISCOPE, LEKSELL FREEHAND
Neurology
186d
Cleared
Mar 02, 1998
LEKSELL STEREOTACTIC SYSTEM
Neurology
252d
Cleared
Apr 24, 1997
ACCESSORIES TO THE STEREOTACTIC BODY FRAM
Radiology
90d
Cleared
Jul 26, 1996
LEKSELL IMAGE GUIDANCE SURGICAL SYSTEM (LIGS)
Neurology
88d
Cleared
Apr 23, 1996
STEREOTACTIC BODY FRAME
Radiology
90d