510(k) Report

Devices descending from K911783

552 later devices reach Allegro Viewing Wand through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K983529Instatrak 3000Visualization Technology, Inc.1998325Class I
+1K982994Skull Base Instatrak SystemVisualization Technology, Inc.1998280Class I
+1K981998Pediatric Instatrak SystemVisualization Technology, Inc.1998327Class I
+1K961834Philips Easyguide NeuroPhilips Medical Systems, Inc.19960—
+1K961844Operating Arm System (Oas) [with CT and MR Images]Radionics Software Applications, Inc.1996158—
+1K960714Isg Viewing WandI.S.G. Technologies, Inc.199671—
+1K961168ViewpointPhilips Medical Systems (Cleveland), Inc.1996161—
+1K955397Mayfield-Acciss WorkstationNomos Corp.199615—
+2K133573Fiagon Navigation SystemFiagon GmbH201428—
+2K060906Calypso 4D Localization SystemCalypso Medical Technologies, Inc.200611—
+2K053610AbarisTraxtal Technologies, Inc.20062783
+2K994270Instatrak 3000 System with Fluorotrak Module, Model IT3000Visualization Technology, Inc.2000294Class I
+2K992843The Mayfield / Acciss System with Windows NT for Cranial Surgery, the Mayfield / Optical…Ohio Medical Instrument Co., Inc.19990—
+2K991636Elekta Stereotactic GuideElekta Instrument AB19990—
+2K991267Spine Applications for the Mayfield/Acciss Operating Arm and Optical Acciss Systems…Ohio Medical Instrument Co., Inc.19990—
+2K984298Z Kat Flurotactic Guidance System MkiZ-Kat, Inc.1999152—
+2K990919Straight Aspirator, 90 Degree Aspirator,45 Degree Aspirator,7 French Aspirator,Extended…Visualization Technology, Inc.19990Class I
+2K984398Liquichek Ana Control, Homogeneous Pattern, Model 201Bio-Rad19980—
+2K982244Mayfield Acciss Optical SystemOhio Medical Instrument Co., Inc.19982—
+2K981424Nomos Bat Ultrasound Localization and Positioning SystemNomos Corp.199810—
+2K973684Leksell Viewscope, Leksell Surgiscope, Leksell FreehandElekta Instrument AB19981—
+2K964229Regulus NavigatorCompass Intl., Inc.199766—
+2K970865Isg Family of Viewing WandsI.S.G. Technologies, Inc.19973—
+2K964801Optical Tracking System (Ots)Radionics Software Applications, Inc.19973—
+2K970604Viewpoint - 3.0 SoftwarePhilips Medical Systems (Cleveland), Inc.1997159—
+2K963221Optical Digitizer Option for View PointPhilips Medical Systems (Cleveland), Inc.1997160—
+3K203722RayPilot SystemMicropos Medical AB20210—
+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—
+3K141456The Fiagon Navigation - Extended Instrument Set Ent, Registrationpointer…Fiagon GmbH201413—
+3K133901Pari-Path Surgical Navigation SystemParitic, Inc.20140—
+3K140823Permanent Beacon Transponder/Soft Tissue Beacon TransponderVarian Medical Systems, Inc.20142—
+3K121498PercunavPhilips Health Care2012222—
+3K121663ClarityElekta, Ltd.20121—
+3K123137Calypso SystemVarian Medical Systems20123—
+3K120187Multi-Modality Image FusionIgt, LLC Dba Eigen20124—
+3K112841Surface Beacon TranspondersCalypso Medical Technologies, Inc.20120—
+3K112768Calypso Systems with Dynamic Edge GatingCalypso Medical Technologies, Inc.20114—
+3K102373Calypso System with Dynamic Edge GatingCalypso Medical Technologies, Inc.20106—
+3K093672Aegis Navigation Anda Egis Pelvic ApplicationSentinelle Medical, Inc.20098—
+3K092619Etrax Needle System, Etrax Variable Angle Needle Guidance System, Virtutrax Universal…Civco20096117
+3K080726Calypso 4D Localization SystemCalypso Medical Technologies, Inc.20089—
+3K080624Navstationirad Emt, Version 1.1Cas Innovations AG200863—
+3K042875NavigatorNomos Corp.20050—
+3K042110BeamcathBeampoint AB20053—
+3K041937RestituResonant Medical, Inc.20043—
+3K032100I-BEAMComputerized Medical Systems, Inc.20034—
+3K022069Oec Fluorotrak 9800 PlusGe Oec Medical Systems20022Class I
+3K013025Modification to Flourolab PlusZ-Kat, Inc.2001151—
+3K992882Leksell Image Guidance Surgical System, View Scope, Surgiscope,Elekta InsightElekta Instrument AB19990—
+3K983764Viewpoint Tools- SterradPhilips Medical Systems (Cleveland), Inc.19990—
+3K990632Optical Tracking System (Ots)Radionics, Inc.19990—
+3K990868Viewpoint Passive Tool OptionPhilips Medical Systems (Cleveland), Inc.19991—
+3K990860Viewpoint Microscope OptionPhilips Medical Systems (Cleveland), Inc.19990—
+3K981480Philips EasyguidePhilips Medical Systems, Inc.19990—
+3K981315NavitrackOrthosoft, Inc.199836—
+3K974602Optical Tracking System (Ots)Radionics Software Applications, Inc.19982—
+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
+4K170570Anchored Beacon (R) transponder, Anchored transponder, Beacon Care Package - LungVarian Medical Systems, Inc.20180—
+4K173628Acclarent ENT Navigation SystemAcclarent, Inc.20182—
+4K171661Scopis Extended Instrument Set EMScopis GmbH20173—
+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—
+4K152761Permanent Beacon Transponder, Soft Tissue Beacon Transponder, Beacon Care Package - Soft…Varian Medical Systems, Inc.20150—
+4K143396omni TRAX Active Patient TrackerCivco Medical Instruments CO Inc Dba Civco Medical Solutions20150—
+4K141459Aplio 500/400/300 Diagnostic Ultrasound System, V5.0Toshibamedical Systems Corporation201439—
+4K141855ClarityElekta, Ltd.20140—
+4K140099Lighthouse Urinary CatheterSeedings Life Science Ventures, LLC20140—
+4K140033TARGET3D FusionConvergent Life Sciences, Inc.20140—
+4K131655Lighthouse (TM) Urinary CatheterSeedings Life Science Ventures, LLC20131—
+4K132304Epiq Diagnostic Ultrasound SystemPhilips Ultrasound, Inc.201321136
+4K132087Percunav SystemPhilips Health Care20139—
+4K131489Tractus Tissuemapper Image Recording System ApplicationTractus Corporation20132—
+4K123901Tractus Tissuemapper Reviewer ApplicationTractus Corporation20132—
+4K111818Sonixgps Needle SensorUltrasonix Medical Corporation201215—
+4K111332Clarity Obp SystemElekta, Ltd.20122—
+4K113680Soma Access Systems Exacttrack Procedure KitSoma Access Systems, LLC201101
+4K093787Iguide CappaCas Innovations GmbH & Co. KG20100—
+4K082919UC-Care Positioning SystemUc-Care Medical Systems, Ltd.20080—
+4K041931Oec Olympus Mobile Fluoroscopy System with Integrated NavigationGe Oec Medical Systems, Inc.200415
+4K031454Acumen Surgical Navigation SystemBiomet, Inc.2004146—
+4K033413Spineassist DeviceMazor Surgical Technologies, Ltd.200435—
+4K031732Ebi Acumen Surgical Navigation SystemEbi, L.P.20030—