Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account

Elekta Instrument AB — Predicate Candidate Screening

35 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.

88 daysmedian FDA review time

181 days90th percentile

35clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K190887	Leksell Vantage Stereotactic System	Elekta Instrument AB	2019-08-01	119	3
K173789	Leksell Gamma Knife Perfexion, Leksell Gamma Knife Icon	Elekta Instrument AB	2018-03-30	106	0
K173791	Leksell GammaPlan	Elekta Instrument AB	2018-02-09	57	1
K171123	Leksell Vantage Stereotactic System	Elekta Instrument AB	2017-09-15	151	1
K160440	Leksell Gamma Knife Icon	Elekta Instrument AB	2016-04-20	63	1
K152558	Leksell Stereotactic System, Injection/ Aspiration Needle Ki	Elekta Instrument AB	2016-03-02	175	3
K151159	Leksell Gamma Knife Perfexion	Elekta Instrument AB	2015-10-29	181	0
K151666	Leksell GammaPlan	Elekta Instrument AB	2015-09-03	76	1
K151561	Leksell Gamma Knife Icon	Elekta Instrument AB	2015-08-04	55	0
K133565	LEKSELL GAMMA KNIFE PERFEXION	Elekta Instrument AB	2014-05-09	170	0
K120811	LEKSELL GAMMA KNIFE PERFEXION	Elekta Instrument AB	2012-05-24	69	1
K103093	LEKSELL GAMMAPLAN	Elekta Instrument AB	2010-12-21	63	1
K092083	EXTEND FRAME SYSTEM, MODEL 1009633	Elekta Instrument AB	2009-09-22	75	1
K090972	LEKSELL GAMMAPLAN	Elekta Instrument AB	2009-07-20	105	0
K080355	LEKSELL STEREOTACTIC SYSTEM WITH REUSABLE FIXATION SCREWS	Elekta Instrument AB	2009-05-01	445	0
K080250	LEKSELL SURGIPLAN, MODEL 1006947	Elekta Instrument AB	2008-05-13	103	0
K063512	LEKSELL GAMMA KNIFE PERFEXION	Elekta Instrument AB	2007-03-05	105	4
K061941	LEKSELL GAMMA KNIFE PERFEXION, MODEL 715000	Elekta Instrument AB	2006-08-21	42	0
K061540	LEKSELL GAMMAPLAN	Elekta Instrument AB	2006-07-05	30	0
K051746	ELEKTA ESARTE FRAME SYSTEM	Elekta Instrument AB	2005-07-25	26	0
K051022	GAMMAPLAN	Elekta Instrument AB	2005-06-01	40	0
K042269	LEKSELL GAMMAPLAN 4C WITH MULTIVIEW	Elekta Instrument AB	2004-09-08	16	0
K040979	ELEKTA MICRODRIVE, MODEL 916716	Elekta Instrument AB	2004-07-23	99	0
K033340	LEKSELL SURGIPLAN WITH IMAGEMERGE	Elekta Instrument AB	2004-02-12	118	0
K031999	ELEKTA LEKSELL STEREOTACTIC SYSTEM WITH MR POST KIT	Elekta Instrument AB	2003-07-25	28	0
K031980	MODIFICATION TO LEKSELL STEREOTACTIC SYSTEM	Elekta Instrument AB	2003-07-25	29	0
K013861	MODIFICATION TO LEKSELL SURGIPLAN WITH ATLASPACE	Elekta Instrument AB	2001-12-06	15	0
K992882	LEKSELL IMAGE GUIDANCE SURGICAL SYSTEM, VIEW SCOPE, SURGISCO	Elekta Instrument AB	1999-09-24	29	0
K991636	ELEKTA STEREOTACTIC GUIDE	Elekta Instrument AB	1999-07-20	69	0
K984328	LEKSELL GAMMA KNIFE TARGET SYSTEM, MODEL 24001	Elekta Instrument AB	1999-05-21	169	4
K973684	LEKSELL VIEWSCOPE, LEKSELL SURGISCOPE, LEKSELL FREEHAND	Elekta Instrument AB	1998-03-31	186	0
K972324	LEKSELL STEREOTACTIC SYSTEM	Elekta Instrument AB	1998-03-02	252	1
K970291	ACCESSORIES TO THE STEREOTACTIC BODY FRAM	Elekta Instrument AB	1997-04-24	90	0
K961639	LEKSELL IMAGE GUIDANCE SURGICAL SYSTEM (LIGS)	Elekta Instrument AB	1996-07-26	88	0
K960338	STEREOTACTIC BODY FRAME	Elekta Instrument AB	1996-04-23	90	0

Methodology

Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.

Prepared with Atlas

Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda