510(k) Report

Devices descending from K052424

17 later devices reach Maxilim through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K161634IPS CaseDesignerNobel Biocare AB20163—
+1K123976NobelclinicianNobel Biocare AB20133—
+1K113732Iplan (Iplan Cranial, Iplan Stereotaxy, Iplan Ent, Iplan CMF, Iplan View, Iplan Spine)Brainlab AG20128—
+2K223106Brainlab Elements Image Fusion, Contouring (4.5);Image Fusion (4.5);Fibertracking…Brainlab AG20231—
+2K212981MirrorMe3D Modeling SystemMirrorme3D, LLC20220—
+2K212420Brainlab Elements, Brainlab Elements Contouring, Brainlab Elements Fibertracking…Brainlab AG20213—
+2K200810IPS CaseDesignerNobel Biocare AB20201—
+2K170816Elements Image Fusion, Elements Cranial Distortion Correction, Elements Spine Curvature…Brainlab AG20175—
+2K163122NobelClinician, DTX Studio implantNobel Biocare AB20172—
+2K140337Brightmatter Planning SoftwareSynaptive Medical, Inc.20141—
+3K260576MeVis AVM ContourMeVis Medical Solutions AG20260—
+3K243633Brainlab Elements (7.0); Brainlab Elements Image Fusion (5.0); Brainlab Elements Image…Brainlab AG20250—
+3K231898DTX Studio Clinic (4.0)Nobel Biocare AB20231—
+3K230276TECHFIT DISRP® SystemTechfit Digital Surgery20230—
+3K190042Brainlab Elements Image Fusion AngioBrainlab AG20190—
+3K180394BrightMatter Plan 1.6.0Synaptive Medical, Inc.20180—
+4K252086DTX Studio AssistNobel Biocare C/O Medicim NV20250—