510(k) Report

Devices descending from K031999

6 later devices reach Elekta Leksell Stereotactic System with MR Post Kit through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K080355Leksell Stereotactic System with Reusable Fixation ScrewsElekta Instrument AB20095—
+2K190887Leksell Vantage Stereotactic SystemElekta Instrument AB201933
+2K171123Leksell Vantage Stereotactic SystemElekta Instrument AB201742
+3K261932Leksell® Vantage Stereotactic SystemElekta Solutions AB20260—
+3K210700NaviNetics D1 Stereotactic SystemNavinetics, Inc.20211—
+4K231392NaviNetics Reusable Stereotactic System (NN1000)Navinetics, Inc.202301