510(k) Report

Devices descending from K001284

751 later devices reach Stealthstation System Goldeneye Micro-Magnetic Tracking System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K200892Harvey (R) Surgical AssistantOrthalign, Inc.202022
+6K193094Naviswiss Hip Navigation SystemNaviswiss AG20201—
+6K201012EPIQ Diagnostic Ultrasound System Series, Affiniti Diagnostic Ultrasound System Series…Philips Ultrasound, Inc.2020185
+6K192495Black Diamond Navigation InstrumentsOsseus Fusion Systems20200—
+6K193375NeuroBlate SystemMonteris Medical,202010—
+6K191722Vital Navigation SystemZimmer Biomet Spine, Inc.20192—
+6K192133Zimmer Biomet Universal Navigation SystemZimmer Biomet Spine, Inc.20190—
+6K191007Aixplorer MACH 30, Aixplorer MACH 20 Ultrasound Diagnostic SystemsSupersonic Imagine20195—
+6K190556Zimmer Biomet Universal Navigation SystemZimmer Biomet Spine, Inc.20190—
+6K191943SYMPHONY Navigation Ready Instruments, Universal Navigation Adaptor SetMedos International SARL20198—
+6K192427Ablation ConfirmationNeuwave Medical, Inc.20191—
+6K192254InnoSight Diagnostic Ultrasound SystemQisda Corporation20190—
+6K183605Spine & Trauma NavigationBrainlab AG2019253
+6K191467Aplio i900/i800/i700/i600 Diagnostic Ultrasound System, V4.0Canon Medical Systems Corporation20199—
+6K191055HS40 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20199—
+6K1910727410 Ultrasound System (MyLabSigma)Esaote, S.p.A.20190—
+6K1909896400 Ultrasound System (MyLabX6, MyLabX7)Esaote, S.p.A.20190—
+6K1904477400 Ultrasound SystemsNavigant Consulting - on Behalf of Esaote S.P.A.20190—
+6K181637DC-70/DC-70T/DC-70 Pro/DC-70 Exp/DC-75/DC-78/DC-70S Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.20198—
+6K182845minisonoAlpinion Medical Systems Co., Ltd.20180—
+6K1831916420 Ultrasound SystemEsaote, S.p.A.20180—
+6K182529Xperius Ultrasound SystemPhilips Ultrasound, Inc.20180—
+6K181485EPIQ , EPIQ 5, EPIQ 7, Affiniti 30, Affiniti 50 and Affiniti 70 Diagnostic Ultrasound…Philips Ultrasound, Inc.20182724
+6K1732916440 Ultrasound SystemEsaote, S.p.A.20188—
+6K173090Aplio i900/i800/i700/i600 Diagnostic Ultrasound System, V2.4Toshibamedical Systems Corporation201821—
+6K173471DC-80/DC-80 PRO/DC-80 EXP/DC-80S/DC-85 DiagnosticShenzhen Mindray Bio-Medical Electronics Co., Ltd.20181—
+6K172056InnoSight Diagnostic Ultrasound SystemQisda Corporation20172—
+6K173372ExactechGPS Total Shoulder ApplicationBlue Ortho2017141
+6K173305NeuroBlate SystemMonteris Medical,201712—
+6K171525Intellijoint HIP Generation 2B SystemIntellijoint Surgical, Inc.20173—
+6K171891ZS3 Ultrasound System, z.one pro Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.20174—
+6K170937VIPER PRIME navigated inserterMedos International SARL20176—
+6K171780OrthAlign Plus SystemOrthalign, Inc.201712—
+6K171034M9 Diagnostic Ultrasound System, M9T Diagnostic Ultrasound System, M9CV Diagnostic…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.201712—
+6K163119NaviSuite SSI EditionMedcom GmbH20171—
+6K170593Mako Total Hip ApplicationMako Surgical Corp.201771
+6K163443Interson USB Ultrasound SystemInterson Corporation20173—
+6K170724NeuroBlate SystemMonteris Medical,201715—
+6K163138Clarius Ultrasound SystemClarius Mobile Health Corp.201628—
+6K162762NeuroBlate SystemMonteris Medical, Inc.201616—
+6K162290MyLabSix CrystaLineEsaote, S.p.A.20160—
+6K162549Lumify Ultrasound SystemPhilips Health Care2016436
+6K162195TSolution One Cup1 Surgical SystemTHINK Surgical, Inc.20167—
+6K161119SonoSite iViz Ultrasound SystemFUJIFILM Sonosite, Inc.20164—
+6K160258X5 Digital Color Doppler Ultrasound SystemSonoscape Medical Corp.20162—
+6K160420SpeqTSignostics Limited20161—
+6K152854S50 Digital Color Doppler Ultrasound SystemSonoscape Medical Corp.201616—
+6K142077MylabgammaEsaote, S.p.A.201453
+6K141983Neuroblate SystemMonteris Medical Corp.2014182
+6K141486Mylabsix Ultrasound SystemEsaote Europe B.V.20148—
+6K140596NAVIOBlue Belt Technologies, Inc.201421—
+6K131955Neuroblate (TM) SystemMonteris Medical, Inc.2013192
+6K131278Monteris Medical Neuroblate SystemMonteris Medical, Inc.2013191
+6K121936NaviopfsBlue Belt Technologies, Inc.2012222
+6K112507Restoris Partial Knee Application (Pka), Rio Standard SystemMako Surgical Corporation2012466
+6K103829Kneealign SystemOrthalign, Inc.201139—
+6K090953Total Knee Surgetics Navigation System with IblockPraxim Medivision, SA2010172
+6K090420Smith & Nephew Pigalileo Screw Targeting System V 1.0Smith & Nephew, Inc.200978—
+7K261272ePascal S/ ePascal SOR/ ePascal S5/ ePascal SA/ ePascal SE/ ePascal 80Elite/ ePascal 80/…Esonic Technology (Wuhan) Co., Ltd.20260—
+7K261852OTS HipOrtoma AB20260—
+7K253507Packaged Assembly, Reusable Navigation Unit; Lantern ASC, Smart Pack kit, KneeOrthalign, Inc.20260—
+7K252558Lumify Diagnostic Ultrasound SystemPhilips Ultrasound, LLC20260—
+7K260240SYMPHONY Navigation Ready InstrumentsMedos International SARL20260—
+7K252557Lumify Diagnostic Ultrasound SystemPhilips Ultrasound, LLC20250—
+7K251931BioTraceIO Vision (V1.7)Techsomed Medical Technologies20250—
+7K243698Alignment System Cranial, with Alignment Software Cranial with LITT; Cirq Alignment…Brainlab AG20250—
+7K242271Caduceus STaiwan Main Orthopaedic Biotechnology Co., Ltd.20240—
+7K243012MIM – Symphony HDR FusionMim Software, Inc.20241—
+7K242616Lantern® HipOrthalign, Inc.20241—
+7K233254TELIGEN System Navigation Ready InstrumentsDePuy Synthes20242—
+7K240662Spine Guidance Software (version 5.0); Xia 3/ Serrato Q Instruments; Everest Q…Stryker Leibinger GmbH & Co KG20247—
+7K240877Monteris Medical NeuroBlate SystemMonteris Medical,20245—
+7K232227Ablate-IQNeuwave Medical, Inc.20240—
+7K234030Clear Guide SCENERGYClear Guide Medical20240—
+7K233734Interson USB Ultrasound SystemInterson Corporation20230—
+7K231354Pocket Ultrasound System (C10)Beijing Konted Medical Technology Co.,Ltd20232—
+7K2301796440 MyLabX90Esaote, S.p.A.202341
+7K233443Vital™ Navigation SystemZimvie Spine (Zimmer Biomet Spine, Inc.)20230—
+7K232500Lumify Diagnostic Ultrasound SystemPhilips Ultrasound202301
+7K230066Carnation series Diagnostic Ultrasound SystemShenzhen Wisonic Medical Technology Co., Ltd.20230—
+7K231280CarboClear® X Pedicle Screw System; CarboClear® X Navigated Instruments; CarboClear® X…CarboFix Orthopedics, Ltd.20234—
+7K222983NeuroBlate Fusion-S Software V3.17Monteris Medical,20237—
+7K223438TELIGEN System Peripheral Motor Nerve Stimulation IndicationsMedos International SARL20230—
+7K223351Naviswiss KneeNaviswiss AG20230—
+7K222510Blueprint Mixed Reality systemTornier S.A.S.2023010
+7K220554Caduceus STaiwan Main Orthopaedic Biotechnology Co., Ltd.20220—
+7K212245Spine and Trauma Navigation System, Spine & Trauma 3D Navigation, Instrument Selection…Brainlab AG202215—
+7K213720Vital Navigation SystemZimvie (Zimmer Biomet Spine, Inc.)20220—
+7K211269Visualase MRI-Guided Laser Ablation System (SW 3.4)Medtronic Navigation, Inc.202271
+7K213546ExactechGPS Total Shoulder Application, Equinoxe Planning SoftwareBlue Ortho202281
+7K211597EPIQ Series Diagnostic Ultrasound System, Affiniti Series Diagnostic Ultrasound SystemPhilips Medical Systems202117—
+7K211300X-CUBE 90Alpinion Medical Systems Co., Ltd.20213—
+7K211299X-CUBE 70Alpinion Medical Systems Co., Ltd.20213—
+7K203645Aixplorer MACH30/ SUPERSONIC MACH30, Aixplorer MACH20/ SUPERSONIC MACH20, SUPERSONIC…Supersonic Imagine20212—
+7K210416M9/M9CV/M9T/M8 Elite/M10/M10CV/Crius M10/M11/M11CV/Crius M11/Operus M11/M9 Premium…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20212—
+7K210153NextAR RSA PlatformMedacta International S.A.202151
+7K203679Automatic RegistrationBrainlab AG20211—
+7K202769VELYS™ Robotic-Assisted SolutionDepuy Ireland UC202131
+7K202455Aixplorer®MACH20, Aixplorer®MACH30, Supersonic MACH40, Supersonic MACH30 & Supersoinc…Supersonic Imagine20200—
+7K202320CIRQ Robotic Alignment Module, Cirq, Cirq Robotic Alignment Module Spinal, Cirq Robotic…Brainlab AG20209—