510(k) Report

Devices descending from K023424

29 later devices reach Igi-System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K150222X-Guide Surgical Navigation SystemX-Nav Technologies, LLC2015261
+1K061224Lapdoc IRobodent GmbH20060—
+1K052840Igi-SystemDenx Advanced Dental Systems20050—
+2K213392INLIANT Surgical Navigation SystemNavigate Surgical Technologies, Inc.20220—
+2K200805Neocis Guidance System (NGS) with Patient SplintsNeocis, Inc.20201—
+2K200662X-Guide® Surgical Navigation SystemX-Nav Technologies, LLC20200—
+2K192579X-Guide Surgical Navigation SystemX-Nav Technologies, LLC20203—
+2K161399Neocis Guidance SystemNeocis, Inc.2016151
+2K161406NavidentClaronav, Inc.20161—
+3K210947NavidentClaronav, Inc.20220—
+3K211701X-Guide® Surgical Navigation SystemX-Nav Technologies, LLC202221
+3K211129Neocis Guidance System (NGS) with Intraoral Fiducial ArrayNeocis, Inc.20210—
+3K203401Neocis Guidance System (NGS) with Patient Splints (EPS)Neocis, Inc.20200—
+3K202264Neocis Guidance System (NGS) with Yomi Plan v2.0Neocis, Inc.20207—
+3K173402Neocis Guidance System (NGS) with Chairside SplintNeocis, Inc.201854
+4K232148X-Guide Surgical Navigation SystemX-Nav Technologies, LLC202412
+4K211466Yomi Robotic System with YomiPlan GoNeocis, Inc.20220—
+4K210711Neocis Guidance System (NGS) with Yomi Plan v2.0.1Neocis, Inc.20215—
+4K202100Neocis Guidance System (NGS) with Clamped Chairside Patient Splint (C-CPS)Neocis, Inc.20200—
+4K200348Neocis Guidance System (NGS) with Fiducial Array Splint (FAS)Neocis, Inc.20200—
+4K182776Neocis Guidance SystemNeocis, Inc.20182—
+5K253954X-Guide Surgical Navigation SystemX-Nav Technologies, LLC20260—
+5K222049Yomi Robotic SystemNeocis, Inc.20224—
+5K191363Neocis Planning Software Application (NPSA) for 3rd Party PCsNeocis, Inc.20190—
+5K191605Neocis Guidance System (NGS)Neocis, Inc.20190—
+6K222750Yomi Robotic SystemNeocis, Inc.20223—
+7K231018Yomi Robotic SystemNeocis, Inc.20232—
+8K252376Yomi S Robotic SystemNeocis, Inc.20250—
+8K251835Yomi Robotic SystemNeocis, Inc.20250—