510(k) Report

Devices descending from K033340

7 later devices reach Leksell Surgiplan with Imagemerge through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K090190Win-Neus Stereotactic Surgery Treatment Planning SystemNuclemed S.A.20090—
+1K080250Leksell Surgiplan, Model 1006947Elekta Instrument AB20085—
+2K092192Waypoint Stereotactic SystemFHC, Inc.20104—
+3K231141STarFix Designer Software C0265FHC, Inc.20230—
+3K223552Brainlab Elements – Trajectory Planning (2.6), Elements Stereotaxy, Elements Lead…Brainlab AG20230—
+3K132611Microtable SystemFred Haer Company, Inc.20141—
+4K233703Bone Anchor (NGS-BA-01)ClearPoint Neuro, Inc.20240—