510(k) Report

Devices descending from K935456

426 later devices reach Regulus Measurement Unit through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K974432Ultraguide 1000Ultraguide, Ltd.1998358—
+1K964229Regulus NavigatorCompass Intl., Inc.199766—
+2K133573Fiagon Navigation SystemFiagon GmbH201428—
+2K093462Sonix Ultrasound ScannerUltrasonix Medical Corporation200979—
+2K092619Etrax Needle System, Etrax Variable Angle Needle Guidance System, Virtutrax Universal…Civco20096117
+2K083728Invision SystemInneroptic Technology, Inc.20098—
+2K080624Navstationirad Emt, Version 1.1Cas Innovations AG200863—
+2K053610AbarisTraxtal Technologies, Inc.20062783
+2K023227USG 2000SAUltraguide, Ltd.2002280—
+2K981315NavitrackOrthosoft, Inc.199836—
+3K211291Cube Navigation System, VirtuEye V2, Navigation Sensor NanoRest, Navigation Unit Cube 4DFiagon GmbH20211—
+3K193502TGS Universal Headrest with Mounting ArmStryker Ent20200—
+3K161491Scopis Hybrid Navigation System EMScopis GmbH20173—
+3K162176Fiagon Navigation SystemFiagon GmbH20164—
+3K161701CARTO ENT SystemBiosense Webster20163—
+3K161555KARL STORZ NAV1 Electromagnetic Navigation SystemKarl Storz Endoscopy America, Inc.20162—
+3K151414IQQA GuideEdda Technology20151—
+3K150473FlexPointer 1.5 mmFiagon GmbH20152—
+3K143396omni TRAX Active Patient TrackerCivco Medical Instruments CO Inc Dba Civco Medical Solutions20150—
+3K141459Aplio 500/400/300 Diagnostic Ultrasound System, V5.0Toshibamedical Systems Corporation201439—
+3K141456The Fiagon Navigation - Extended Instrument Set Ent, Registrationpointer…Fiagon GmbH201413—
+3K133901Pari-Path Surgical Navigation SystemParitic, Inc.20140—
+3K131489Tractus Tissuemapper Image Recording System ApplicationTractus Corporation20132—
+3K121498PercunavPhilips Health Care2012222—
+3K121479AIMInneroptic Technology, Inc.20125—
+3K111818Sonixgps Needle SensorUltrasonix Medical Corporation201215—
+3K120187Multi-Modality Image FusionIgt, LLC Dba Eigen20124—
+3K113680Soma Access Systems Exacttrack Procedure KitSoma Access Systems, LLC201101
+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—
+3K033413Spineassist DeviceMazor Surgical Technologies, Ltd.200435—
+4K261540Cube 4D Navigation System, VirtuEye ProFiagon GmbH20260—
+4K221098Scopis ENT Software, Scopis ENT Software with TGS, Scopis Planning Software…Stryker Corporation202201
+4K201174TruDi CuretteAcclarent, Inc.20200—
+4K193453TruDi ProbeAcclarent, Inc.20200—
+4K200041FlexPointer 1.5 Single Use, FlexTube 3 Single UseFiagon GmbH20200—
+4K193118TGS Guidewire and updated Scopis SoftwareStryker Ent20201—
+4K192397TruDi Navigation SystemBiosense Webster202011
+4K180948TruDi NAV Suction InstrumentsAcclarent, Inc.201805
+4K162314IMACTIS CT-Navigation systemImactis, Sas201804
+4K173628Acclarent ENT Navigation SystemAcclarent, Inc.20182—
+4K171309BR-FHUS Navigation 1.0Taihao Medical, Inc.20171—
+4K171661Scopis Extended Instrument Set EMScopis GmbH20173—
+4K171105AIXPLORER® & AIXPLORER® Ultimate Ultrasound SystemsSupersonic Imagine201719—
+4K163416Fiagon Navigation – PointerTube Straight and PointerTube KeatFiagon GmbH20170—
+4K161697Acclarent NavWire Sinus Navigation GuidewireAcclarent, Inc.20163—
+4K161109iSR'obot MRI-US FusionBiobot Surgical Pte., Ltd.20162—
+4K160479PointerShell Universal, PointerShell LSFiagon GmbH20160—
+4K160369GuideWireFiagon GmbH20163—
+4K151451Aplio 500/400/300 Diagnostic Ultrasound System V6.0Toshibamedical Systems Corporation2015342
+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—
+4K140254EZONO 4000Ezono AG201413—
+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—
+4K073467Spineassist SystemMazor Surgical Technologies, Ltd.200832—
+4K063607Spineassist SystemMazor Surgical Technologies, Ltd.200733—
+4K051676Spineassist Device with Additional AccessoriesMazor Surgical Technologies, Ltd.200534—
+5K231862TruDi® Navigation System V3 (FG-2000-00)Acclarent, Inc.202301
+5K211529NAVIRFA ScopeNavifus Corporation20220—
+5K213411iSR’obot Mona Lisa 2.0Biobot Surgical Pte., Ltd.20211—
+5K211098Breast Volume Navigator (BVN) Model G-2000Metritrack, Inc.20210—
+5K202609Instrument Clamps ElectromagneticStryker Corporation20200—
+5K202119AcuSee AS-P1000 SystemWeipeng (Suzhou) Medical Devices Co., Ltd.20200—
+5K190120Vinno 8, Vinno 6, Vinno 5Vinno Technology (Suzhou) Co.,Ltd20201—
+5K190532TruDi NAV WireAcclarent, Inc.20190—
+5K182894HM70A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201910—
+5K181124Acessa ProVu SystemAcessa Health, Inc.20180—
+5K173021Aixplorer & Aixplorer Ultimate Ultrasound Diagnostic SystemsSupersonic Imagine201818—
+5K171709BR-FHUS Viewer 1.0Taihao Medical, Inc.20171—
+5K171687Relieva SpinPlus Nav Balloon Sinuplasty SystemAcclarent, Inc.20171—
+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
+5K161940Guidewire 0.6 Single UseFiagon GmbH20162—
+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—