510(k) Report

Devices descending from K882383

368 later devices reach Maggi Series Ultra. Needle, Biopsy/Catheter Guides through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K093713Ultrasound General Purpose Guidance SystemCivco Medical Instruments201047
+1K092619Etrax Needle System, Etrax Variable Angle Needle Guidance System, Virtutrax Universal…Civco20096117
+1K043425Sheathes Needle Guide, Model NG-SR-a-484-Kit (There Will BE Various Model Numbers Based…Sheathing Technologies, Inc.20054—
+1K974432Ultraguide 1000Ultraguide, Ltd.1998358—
+2K260114Align® Cover and Pad Guidance ToolCIVCO Medical Instruments Co., Inc.20260—
+2K262474ND Needle Guidance SystemAccurate Access, LLC20260—
+2K171040Reusable guides ranges (PERINE range, NAIL range, CON-LEAD range and LIN-LEAD range) and…Koelis20170—
+2K143396omni TRAX Active Patient TrackerCivco Medical Instruments CO Inc Dba Civco Medical Solutions20150—
+2K141459Aplio 500/400/300 Diagnostic Ultrasound System, V5.0Toshibamedical Systems Corporation201439—
+2K133901Pari-Path Surgical Navigation SystemParitic, Inc.20140—
+2K131489Tractus Tissuemapper Image Recording System ApplicationTractus Corporation20132—
+2K111818Sonixgps Needle SensorUltrasonix Medical Corporation201215—
+2K111426Euclid (TM) Tier 1-GW Access SystemHouston Medical Robotics20120—
+2K113680Soma Access Systems Exacttrack Procedure KitSoma Access Systems, LLC201101
+2K093462Sonix Ultrasound ScannerUltrasonix Medical Corporation200979—
+2K083728Invision SystemInneroptic Technology, Inc.20098—
+2K083667Needle Guide for 8814, Model UA1335, Needle Guide for 8815, Model UA 1336, Needle Guide…B-K Medical Aps20093—
+2K080624Navstationirad Emt, Version 1.1Cas Innovations AG200863—
+2K053610AbarisTraxtal Technologies, Inc.20062783
+2K023227USG 2000SAUltraguide, Ltd.2002280—
+3K171309BR-FHUS Navigation 1.0Taihao Medical, Inc.20171—
+3K171105AIXPLORER® & AIXPLORER® Ultimate Ultrasound SystemsSupersonic Imagine201719—
+3K160806Verza Guidance SystemCIVCO Medical Instruments Co., Inc.20162—
+3K151414IQQA GuideEdda Technology20151—
+3K151451Aplio 500/400/300 Diagnostic Ultrasound System V6.0Toshibamedical Systems Corporation2015342
+3K140254EZONO 4000Ezono AG201413—
+3K121498PercunavPhilips Health Care2012222—
+3K121479AIMInneroptic Technology, Inc.20125—
+3K120187Multi-Modality Image FusionIgt, LLC Dba Eigen20124—
+3K112726Sonix Ultrasound ScannerUltrasonix Medical Corporation20110—
+3K101979Explorer Liver (Passive Tracking)Pathfinder Therapeutics, Inc.20111—
+3K102997Sonixtablet Ultrasound ScannerUltrasonix Medical Corporation201077—
+3K093787Iguide CappaCas Innovations GmbH & Co. KG20100—
+3K093672Aegis Navigation Anda Egis Pelvic ApplicationSentinelle Medical, Inc.20098—
+3K081984Laborpro SystemTrig Medical, Ltd.20090—
+4K250524Mendaera Guidance SystemMendaera, Inc.20250—
+4K211098Breast Volume Navigator (BVN) Model G-2000Metritrack, Inc.20210—
+4K190120Vinno 8, Vinno 6, Vinno 5Vinno Technology (Suzhou) Co.,Ltd20201—
+4K182894HM70A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201910—
+4K162314IMACTIS CT-Navigation systemImactis, Sas201804
+4K173021Aixplorer & Aixplorer Ultimate Ultrasound Diagnostic SystemsSupersonic Imagine201818—
+4K163702Aplio i900/i800/i700 Diagnostic Ultrasound System, V2.1Toshibamedical Systems Corporation2017221
+4K1630826200 Ultrasound System and 6250 Ultrasound SystemEsaote, S.p.A.201792
+4K161109iSR'obot MRI-US FusionBiobot Surgical Pte., Ltd.20162—
+4K161843Aplio i900/i800/i700 Diagnostic Ultrasound System, V2.0Toshibamedical Systems Corporation2016231
+4K143024CAS-One LiverCascination AG20150—
+4K142054Imacor Zura Evo Imaging SystemImacor, Inc.201401
+4K141806Clear Guide OneClear Guide Medical20142—
+4K132744Acessa Guidance SystemHalt Medical, Inc.20141—
+4K140033TARGET3D FusionConvergent Life Sciences, Inc.20140—
+4K132304Epiq Diagnostic Ultrasound SystemPhilips Ultrasound, Inc.201321136
+4K132087Percunav SystemPhilips Health Care20139—
+4K123901Tractus Tissuemapper Reviewer ApplicationTractus Corporation20132—
+4K123001Acuson X700 Diagnstic Ultrasound SystemSiemens Medical Solutions USA, Inc.2012742
+4K113663Sonixtablet Ultrasound ScannerUltrasonix Medical Corporation201275—
+5K221911Vinno 6PRO, Vinno 6EXP, Vinno 5PRO, Vinno 5EXP, Vinno 3, Vinno 3PRO, Vinno 3EXPVinno Technology (Suzhou) Co.,Ltd20220—
+5K211529NAVIRFA ScopeNavifus Corporation20220—
+5K213411iSR’obot Mona Lisa 2.0Biobot Surgical Pte., Ltd.20211—
+5K202119AcuSee AS-P1000 SystemWeipeng (Suzhou) Medical Devices Co., Ltd.20200—
+5K200655FibroScan® 630Echosens20200—
+5K191055HS40 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20199—
+5K181124Acessa ProVu SystemAcessa Health, Inc.20180—
+5K180572AIXPLORER MACH Ultrasound Diagnostic Systems Aixplorer Mach 30, Aixplorer Mach 20…Supersonic Imagine201816—
+5K1732916440 Ultrasound SystemEsaote, S.p.A.20188—
+5K173090Aplio i900/i800/i700/i600 Diagnostic Ultrasound System, V2.4Toshibamedical Systems Corporation201821—
+5K171709BR-FHUS Viewer 1.0Taihao Medical, Inc.20171—
+5K170716PercuNav Image Fusion and Interventional NavigationPhilips Ultrasound, Inc.20173—
+5K163120EPIQ 5 Diagnostic Ultrasound System; EPIQ 7 Diagnostic Ultrasound System; Affiniti 50…Philips Ultrasound, Inc.20175828
+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—
+5K142876ACUSON S1000/ S2000/ S3000 Diagnostic Ultrasound SystemsSiemens Medical Solutions USA, Inc.2014581
+5K142395SC2000 and ACUSON X300 Diagnostic Ultrasound SystemsSiemens Medical Solutions USA, Inc.20140—
+5K141846Acuson X700 Ultrasound System, Acuson X600 Ultrasound SystemSiemens Medical Solutions USA, Inc.201441—
+5K140808Q-StationPhilips Ultrasound, Inc.201402
+5K133833Nuvis Diagnostic Ultrasound SystemPhilips Ultrasound, Inc.2014873
+5K132804Acuson S1000 / S2000 / S3000Siemens Medical Solutions USA, Inc. Ultrasound Gro2013733
+6K260123EPIQ Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC202601
+6K232320iSR`obot Mona Lisa 2.0Biobot Surgical Pte., Ltd.20230—
+6K2301796440 MyLabX90Esaote, S.p.A.202341
+6K192914Stimuplex Onvision SystemPhilips Medical Systems Nederland B.V.20200—
+6K201053PercuNav Image Fusion and Interventional NavigationPhilips Ultrasound, Inc.20201—
+6K200339HS40 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20208—
+6K193510Terason uSmart3200T Ultrasound SystemTeratech Corporation20201—
+6K1921576450 Ultrasound systemEsaote, S.p.A.20194—
+6K191007Aixplorer MACH 30, Aixplorer MACH 20 Ultrasound Diagnostic SystemsSupersonic Imagine20195—
+6K191467Aplio i900/i800/i700/i600 Diagnostic Ultrasound System, V4.0Canon Medical Systems Corporation20199—
+6K182594E-CUBE i7Alpinion Medical Systems Co., Ltd.20191—
+6K1831916420 Ultrasound SystemEsaote, S.p.A.20180—
+6K182427Aplio a550 and a450, Software V2.8 Diagnostic Ultrasound SystemCanon Medical Systems Corporation20184—
+6K182679Aplio i900/i800/i700/i600 Diagnostic Ultrasound System, V3.1Canon Medical Systems Corporation201810—
+6K181617E-CUBE 8Alpinion Medical Systems Co., Ltd.20180—
+6K181277E-CUBE 12Alpinion Medical Systems Co., Ltd.20187—