FDA 510(k) Applications Submitted by ELEKTA INSTRUMENT AB

FDA 510(k) Number Submission Date Device Name Applicant
K092083 07/09/2009 EXTEND FRAME SYSTEM, MODEL 1009633 ELEKTA INSTRUMENT AB
K160440 02/17/2016 Leksell Gamma Knife Icon Elekta Instrument AB
K173789 12/14/2017 Leksell Gamma Knife Perfexion, Leksell Gamma Knife Icon Elekta Instrument AB
K090972 04/06/2009 LEKSELL GAMMAPLAN ELEKTA INSTRUMENT AB
K040979 04/15/2004 ELEKTA MICRODRIVE, MODEL 916716 ELEKTA INSTRUMENT AB
K042269 08/23/2004 LEKSELL GAMMAPLAN 4C WITH MULTIVIEW ELEKTA INSTRUMENT AB
K063512 11/20/2006 LEKSELL GAMMA KNIFE PERFEXION ELEKTA INSTRUMENT AB
K103093 10/19/2010 LEKSELL GAMMAPLAN ELEKTA INSTRUMENT AB
K960338 01/24/1996 STEREOTACTIC BODY FRAME ELEKTA INSTRUMENT AB
K991636 05/12/1999 ELEKTA STEREOTACTIC GUIDE ELEKTA INSTRUMENT AB
K972324 06/23/1997 LEKSELL STEREOTACTIC SYSTEM ELEKTA INSTRUMENT AB
K992882 08/26/1999 LEKSELL IMAGE GUIDANCE SURGICAL SYSTEM, VIEW SCOPE, SURGISCOPE,ELEKTA INSIGHT ELEKTA INSTRUMENT AB
K013861 11/21/2001 MODIFICATION TO LEKSELL SURGIPLAN WITH ATLASPACE ELEKTA INSTRUMENT AB
K984328 12/03/1998 LEKSELL GAMMA KNIFE TARGET SYSTEM, MODEL 24001 ELEKTA INSTRUMENT AB
K973684 09/26/1997 LEKSELL VIEWSCOPE, LEKSELL SURGISCOPE, LEKSELL FREEHAND ELEKTA INSTRUMENT AB
K152558 09/09/2015 Leksell Stereotactic System, Injection/ Aspiration Needle Kit ELEKTA INSTRUMENT AB
K061540 06/05/2006 LEKSELL GAMMAPLAN ELEKTA INSTRUMENT AB
K171123 04/17/2017 Leksell Vantage Stereotactic System Elekta Instrument AB
K151159 05/01/2015 Leksell Gamma Knife Perfexion ELEKTA INSTRUMENT AB
K151561 06/10/2015 Leksell Gamma Knife Icon ELEKTA INSTRUMENT AB
K151666 06/19/2015 Leksell GammaPlan ELEKTA INSTRUMENT AB
K133565 11/20/2013 LEKSELL GAMMA KNIFE PERFEXION ELEKTA INSTRUMENT AB
K173791 12/14/2017 Leksell GammaPlan Elekta Instrument AB
K080250 01/31/2008 LEKSELL SURGIPLAN, MODEL 1006947 ELEKTA INSTRUMENT AB
K080355 02/11/2008 LEKSELL STEREOTACTIC SYSTEM WITH REUSABLE FIXATION SCREWS ELEKTA INSTRUMENT AB
K051022 04/22/2005 GAMMAPLAN ELEKTA INSTRUMENT AB
K031980 06/26/2003 MODIFICATION TO LEKSELL STEREOTACTIC SYSTEM ELEKTA INSTRUMENT AB
K031999 06/27/2003 ELEKTA LEKSELL STEREOTACTIC SYSTEM WITH MR POST KIT ELEKTA INSTRUMENT AB
K051746 06/29/2005 ELEKTA ESARTE FRAME SYSTEM ELEKTA INSTRUMENT AB
K061941 07/10/2006 LEKSELL GAMMA KNIFE PERFEXION, MODEL 715000 ELEKTA INSTRUMENT AB
K033340 10/17/2003 LEKSELL SURGIPLAN WITH IMAGEMERGE ELEKTA INSTRUMENT AB
K970291 01/24/1997 ACCESSORIES TO THE STEREOTACTIC BODY FRAM ELEKTA INSTRUMENT AB
K961639 04/29/1996 LEKSELL IMAGE GUIDANCE SURGICAL SYSTEM (LIGS) ELEKTA INSTRUMENT AB
K120811 03/16/2012 LEKSELL GAMMA KNIFE PERFEXION ELEKTA INSTRUMENT AB


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