510(k) Report

Devices descending from K212420

3 later devices reach Brainlab Elements, Brainlab Elements Contouring, Brainlab Elements… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K260576MeVis AVM ContourMeVis Medical Solutions AG20260—
+1K223106Brainlab Elements Image Fusion, Contouring (4.5);Image Fusion (4.5);Fibertracking…Brainlab AG20231—
+2K243633Brainlab Elements (7.0); Brainlab Elements Image Fusion (5.0); Brainlab Elements Image…Brainlab AG20250—