510(k) Report

Devices descending from K170816

5 later devices reach Elements Image Fusion, Elements Cranial Distortion Correction, Elements Spine… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K212420Brainlab Elements, Brainlab Elements Contouring, Brainlab Elements Fibertracking…Brainlab AG20213—
+1K190042Brainlab Elements Image Fusion AngioBrainlab AG20190—
+2K260576MeVis AVM ContourMeVis Medical Solutions AG20260—
+2K223106Brainlab Elements Image Fusion, Contouring (4.5);Image Fusion (4.5);Fibertracking…Brainlab AG20231—
+3K243633Brainlab Elements (7.0); Brainlab Elements Image Fusion (5.0); Brainlab Elements Image…Brainlab AG20250—