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Elekta Instrument AB

FDA 510(k) & PMA Approved Devices — 6 products

Total Devices6
Categories2
Latest FDA decision2019-08-01
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
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