Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Elekta Instrument AB

FDA 510(k) & PMA Approved Devices — 31 products

Total Devices31
Categories0
Latest FDA decision
TypeNumberDevice NameCodeDateActions
510(k) K190887 Leksell Vantage Stereotactic SystemHAW2019-08-01 View
510(k) K173789 Leksell Gamma Knife Perfexion, Leksell Gamma Knife IconIWB2018-03-30 View
510(k) K173791 Leksell GammaPlanIWB2018-02-09 View
510(k) K171123 Leksell Vantage Stereotactic SystemHAW2017-09-15 View
510(k) K160440 Leksell Gamma Knife IconIWB2016-04-20 View
510(k) K152558 Leksell Stereotactic System, Injection/ Aspiration Needle KitHAW2016-03-02 View
510(k) K120811 LEKSELL GAMMA KNIFE PERFEXIONIWB2012-05-24 View
510(k) K103093 LEKSELL GAMMAPLANMUJ2010-12-21 View
510(k) K092083 EXTEND FRAME SYSTEM, MODEL 1009633IWB2009-09-22 View
510(k) K090972 LEKSELL GAMMAPLANMUJ2009-07-20 View
510(k) K080355 LEKSELL STEREOTACTIC SYSTEM WITH REUSABLE FIXATION SCREWSHAW2009-05-01 View
510(k) K080250 LEKSELL SURGIPLAN, MODEL 1006947HAW2008-05-13 View
510(k) K063512 LEKSELL GAMMA KNIFE PERFEXIONIWB2007-03-05 View
510(k) K061941 LEKSELL GAMMA KNIFE PERFEXION, MODEL 715000IWB2006-08-21 View
510(k) K061540 LEKSELL GAMMAPLANIWB2006-07-05 View
510(k) K051746 ELEKTA ESARTE FRAME SYSTEMHAW2005-07-25 View
510(k) K051022 GAMMAPLANIWB2005-06-01 View
510(k) K042269 LEKSELL GAMMAPLAN 4C WITH MULTIVIEWMUJ2004-09-08 View
510(k) K040979 ELEKTA MICRODRIVE, MODEL 916716HAW2004-07-23 View
510(k) K033340 LEKSELL SURGIPLAN WITH IMAGEMERGEHAW2004-02-12 View
↑