510(k) Report

Devices descending from K081347

26 later devices reach Iluma Vision through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K123519Invivo DentalAnatomage, Inc.201324—
+1K094064Iluma Vision Model Version 2.23M Imtec20100—
+2K200572Planmeca RomexisPlanmeca Oy20202—
+2K181926InVivo Web ViewerAnatomage, Inc.20180—
+2K171385Planmeca RomexisPlanmeca Oy20171—
+2K140713Planmeca RomexisPlanmeca Oy201414—
+2K140093TABLEAnatomage, Inc.20144—
+3K260716NeowiseCefla S.C.20260—
+3K251514Overjet CBCT AssistOverjet, Inc.20250—
+3K192165Acteon Imaging SuiteDe Gotzen S.R.L.20200—
+3K162799CliniviewPalodex Group OY201713—
+3K142048Emprint Procedure Planning ApplicationCovidien, LLC20143—
+4K203156DTX Studio ClinicNobel Biocare AB202010—
+4K180192Emprint Ablation Visualization ApplicationCovidien, LLC20182—
+4K172224DTX Studio diagnoseNobel Biocare AB20180—
+5K213562DTX Studio Clinic 3.0Nobel Biocare AB20229—
+5K192038Emprint Visualization ApplicationCovidien, LLC20191—
+6K252947HistoSonics® Planning ToolHistoSonics, Inc.20260—
+6K233925Relu CreatorRelu BV20246—
+6K231898DTX Studio Clinic (4.0)Nobel Biocare AB20231—
+7K260785DS Core CBCT AnatomyDentsply Sirona20261—
+7K252538CEPHX3DOrca Dental AI, Ltd.20260—
+7K252086DTX Studio AssistNobel Biocare C/O Medicim NV20250—
+7K243989Second Opinion® 3DPearl, Inc.20253—
+8K262127DS Core CBCT AnatomyDentsply Sirona20260—
+8K254096VELMENI for DENTISTS (V4D) 3DVelmeni, Inc.20260—