510(k) Report

Devices descending from K113732

8 later devices reach Iplan (Iplan Cranial, Iplan Stereotaxy, Iplan Ent, Iplan CMF, Iplan View… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K223106Brainlab Elements Image Fusion, Contouring (4.5);Image Fusion (4.5);Fibertracking…Brainlab AG20231—
+1K212420Brainlab Elements, Brainlab Elements Contouring, Brainlab Elements Fibertracking…Brainlab AG20213—
+1K170816Elements Image Fusion, Elements Cranial Distortion Correction, Elements Spine Curvature…Brainlab AG20175—
+1K140337Brightmatter Planning SoftwareSynaptive Medical, Inc.20141—
+2K260576MeVis AVM ContourMeVis Medical Solutions AG20260—
+2K243633Brainlab Elements (7.0); Brainlab Elements Image Fusion (5.0); Brainlab Elements Image…Brainlab AG20250—
+2K190042Brainlab Elements Image Fusion AngioBrainlab AG20190—
+2K180394BrightMatter Plan 1.6.0Synaptive Medical, Inc.20180—