510(k) Report

Devices descending from K020631

343 later devices reach IPLAN through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K042543Iplan! Digital TemplatingBrainlab AG20057—
+1K041703IPLAN!Brainlab AG200456—
+1K041330Iplan! FlowBrainlab AG20042—
+1K040050Instatrak System with Multiple Dataset Navigation, Model IT3500Ge Medical Systems Navigation and Visualization IN2004280Class I
+1K032511Intuition ImageBrainlab AG200435—
+2K092619Etrax Needle System, Etrax Variable Angle Needle Guidance System, Virtutrax Universal…Civco20096117
+2K091000KneekgEmovi20090—
+2K080886Iplan RT ImageBrainlab AG200833—
+2K080608Digital LightboxBrainlab AG20086—
+2K053610AbarisTraxtal Technologies, Inc.20062783
+2K053164Iplan FlowBrainlab AG20061—
+2K053127IPLANBrainlab AG200654—
+2K052220Iplan RT FibertrackingBrainlab AG200534—
+3K201435Molecular Flow SimulationsTherataxis, LLC20210—
+3K151414IQQA GuideEdda Technology20151—
+3K143396omni TRAX Active Patient TrackerCivco Medical Instruments CO Inc Dba Civco Medical Solutions20150—
+3K141459Aplio 500/400/300 Diagnostic Ultrasound System, V5.0Toshibamedical Systems Corporation201439—
+3K133901Pari-Path Surgical Navigation SystemParitic, Inc.20140—
+3K131489Tractus Tissuemapper Image Recording System ApplicationTractus Corporation20132—
+3K121498PercunavPhilips Health Care2012222—
+3K111818Sonixgps Needle SensorUltrasonix Medical Corporation201215—
+3K120187Multi-Modality Image FusionIgt, LLC Dba Eigen20124—
+3K113680Soma Access Systems Exacttrack Procedure KitSoma Access Systems, LLC201101
+3K101627IPLANBrainlab AG201112—
+3K103246Iplan RTBrainlab AG2011322
+3K093117Digital LightboxBrainlab AG200952
+3K093672Aegis Navigation Anda Egis Pelvic ApplicationSentinelle Medical, Inc.20098—
+3K080624Navstationirad Emt, Version 1.1Cas Innovations AG200863—
+4K211544Trajectory Planning, Elements Trajectory Planning, Elements Lead LocalizationBrainlab AG20211—
+4K203681RT Elements, Cranial SRS w/ Cones, Multiple Brain Mets SRS, Cranial SRS, Spine SRS, RT…Brainlab AG20212—
+4K162314IMACTIS CT-Navigation systemImactis, Sas201804
+4K171309BR-FHUS Navigation 1.0Taihao Medical, Inc.20171—
+4K163666neuro inspireRensihaw Plc20170—
+4K171105AIXPLORER® & AIXPLORER® Ultimate Ultrasound SystemsSupersonic Imagine201719—
+4K161109iSR'obot MRI-US FusionBiobot Surgical Pte., Ltd.20162—
+4K153653DICOM ViewerBrainlab AG20164—
+4K151451Aplio 500/400/300 Diagnostic Ultrasound System V6.0Toshibamedical Systems Corporation2015342
+4K142108RT Elements, Dose Review, Brain Metastases, Adaptive Hybrid Surgery AnalysisBrainlab AG201453
+4K140033TARGET3D FusionConvergent Life Sciences, Inc.20140—
+4K140254EZONO 4000Ezono AG201413—
+4K132304Epiq Diagnostic Ultrasound SystemPhilips Ultrasound, Inc.201321136
+4K132087Percunav SystemPhilips Health Care20139—
+4K123901Tractus Tissuemapper Reviewer ApplicationTractus Corporation20132—
+4K113732Iplan (Iplan Cranial, Iplan Stereotaxy, Iplan Ent, Iplan CMF, Iplan View, Iplan Spine)Brainlab AG20128—
+4K120387RaystationRaysearch Laboratories AB2012226
+4K093787Iguide CappaCas Innovations GmbH & Co. KG20100—
+5K223106Brainlab Elements Image Fusion, Contouring (4.5);Image Fusion (4.5);Fibertracking…Brainlab AG20231—
+5K223552Brainlab Elements – Trajectory Planning (2.6), Elements Stereotaxy, Elements Lead…Brainlab AG20230—
+5K223279RT Elements (4.0)Brainlab AG20231—
+5K213411iSR’obot Mona Lisa 2.0Biobot Surgical Pte., Ltd.20211—
+5K212420Brainlab Elements, Brainlab Elements Contouring, Brainlab Elements Fibertracking…Brainlab AG20213—
+5K211098Breast Volume Navigator (BVN) Model G-2000Metritrack, Inc.20210—
+5K202284OncospaceOncospace, Inc.20214—
+5K190120Vinno 8, Vinno 6, Vinno 5Vinno Technology (Suzhou) Co.,Ltd20201—
+5K191014Elements ViewerBrainlab AG20203—
+5K182894HM70A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201910—
+5K173021Aixplorer & Aixplorer Ultimate Ultrasound Diagnostic SystemsSupersonic Imagine201818—
+5K171709BR-FHUS Viewer 1.0Taihao Medical, Inc.20171—
+5K170816Elements Image Fusion, Elements Cranial Distortion Correction, Elements Spine Curvature…Brainlab AG20175—
+5K163702Aplio i900/i800/i700 Diagnostic Ultrasound System, V2.1Toshibamedical Systems Corporation2017221
+5K170716PercuNav Image Fusion and Interventional NavigationPhilips Ultrasound, Inc.20173—
+5K1630826200 Ultrasound System and 6250 Ultrasound SystemEsaote, S.p.A.201792
+5K163120EPIQ 5 Diagnostic Ultrasound System; EPIQ 7 Diagnostic Ultrasound System; Affiniti 50…Philips Ultrasound, Inc.20175828
+5K161843Aplio i900/i800/i700 Diagnostic Ultrasound System, V2.0Toshibamedical Systems Corporation2016231
+5K160807EPIQ 5 Diagnostic Ultrasound System, EPIQ 7Diagnostic Ultrasound System, Affiniti 50…Philips Ultrasound, Inc.201610033
+5K153004Clear Guide SCENERGYClear Guide Medical20164—
+5K153480ClearVue850 Diagnostic Ultrasound SystemPhilips Health Care2015210
+5K150773E-CUBE 15 Diagnostic Ultrasound SystemAlpinion Medical Systems Co., Ltd.201515—
+5K150533Terason uSmart3200T Ultrasound SystemTeratech Corp.20152—
+5K150148Terason uSmart3300 Ultrasound SystemTeratech Corp.20150—
+5K142714S8 Exp/S9 Pro Portable Digital Color Doppler Ultrasound SystemSonoscape Company Limited20154—
+5K142815S22 Digital Color Doppler Ultrasound SystemSonoscape Company Limited20152—
+5K142710S9 Portable Digital Color Doppler Ultrasound SystemSonoscape Company Limited201519—
+5K142474S12 Digital Color Doppler Ultrasound SystemSonoscape Company Limited20144—
+5K140337Brightmatter Planning SoftwareSynaptive Medical, Inc.20141—
+5K140808Q-StationPhilips Ultrasound, Inc.201402
+5K133833Nuvis Diagnostic Ultrasound SystemPhilips Ultrasound, Inc.2014873
+5K130617RaystationRaysearch Laboratories AB2013216
+6K260576MeVis AVM ContourMeVis Medical Solutions AG20260—
+6K260123EPIQ Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC202601
+6K254265Helion Viewer SuiteVideomed Srl ( a Baxter Healthcare Corp company)20260—
+6K250440RT Elements (4.5); (Elements) Multiple Brain Mets SRS; (Elements) Cranial SRS…Brainlab AG20250—
+6K243633Brainlab Elements (7.0); Brainlab Elements Image Fusion (5.0); Brainlab Elements Image…Brainlab AG20250—
+6K232759Viewer (5.4); Elements Viewer; Mixed Reality Viewer; Smart Layout; Elements Viewer Smart…Brainlab AG202411
+6K232320iSR`obot Mona Lisa 2.0Biobot Surgical Pte., Ltd.20230—
+6K222803OncospaceOncospace, Inc.20233—
+6K221911Vinno 6PRO, Vinno 6EXP, Vinno 5PRO, Vinno 5EXP, Vinno 3, Vinno 3PRO, Vinno 3EXPVinno Technology (Suzhou) Co.,Ltd20220—
+6K200655FibroScan® 630Echosens20200—
+6K192914Stimuplex Onvision SystemPhilips Medical Systems Nederland B.V.20200—
+6K201053PercuNav Image Fusion and Interventional NavigationPhilips Ultrasound, Inc.20201—
+6K193510Terason uSmart3200T Ultrasound SystemTeratech Corporation20201—
+6K191055HS40 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20199—
+6K190042Brainlab Elements Image Fusion AngioBrainlab AG20190—
+6K182594E-CUBE i7Alpinion Medical Systems Co., Ltd.20191—
+6K181617E-CUBE 8Alpinion Medical Systems Co., Ltd.20180—
+6K181277E-CUBE 12Alpinion Medical Systems Co., Ltd.20187—
+6K180572AIXPLORER MACH Ultrasound Diagnostic Systems Aixplorer Mach 30, Aixplorer Mach 20…Supersonic Imagine201816—
+6K180394BrightMatter Plan 1.6.0Synaptive Medical, Inc.20180—
+6K1732916440 Ultrasound SystemEsaote, S.p.A.20188—
+6K173090Aplio i900/i800/i700/i600 Diagnostic Ultrasound System, V2.4Toshibamedical Systems Corporation201821—