510(k) Report

Devices descending from K003589

882 later devices reach Vectorvision Cranial, Vectorvision Spinal, Vectorvision Ent through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+7K162313NuVasive Next Generation NVM5 SystemNu Vasive, Incorporated20177—
+7K170430TSolution One Surgical System Model 210THINK Surgical, Inc.20176—
+7K163020Xperius Ultrasound SystemPhilips Health Care201611
+7K161439E-CUBE 11Alpinion Medical Systems Co., Ltd.201612—
+7K162329CX50 Diagnostic Ultrasound System, Sparq Diagnostic Ultrasound SystemPhilips Health Care2016273
+7K153424E-CUBE i7Alpinion Medical Systems Co., Ltd.201614—
+7K152983FUJIFILM SonoSite iViz Ultrasound SystemFUJIFILM Sonosite, Inc.20155—
+7K152899Philips Lumify Diagnostic Ultrasound SystemPhilips Healthcare, Inc.2015794
+7K142530Partial Knee Application (PKA)Mako Surgical Corporation20153—
+7K152396S12 Digital Color Doppler Ultrasound SystemSonoscape Medical Corp.20151—
+7K152164S8 Exp/S9 Pro Portable Digital Color Doppler Ultrasound SystemSonoscape Medical Corp.20153—
+7K152165S9 Portable Digital Color Doppler Ultrasound SystemSonoscape Medical Corp.201502
+7K143752Total Knee Application (TKA)Mako Surgical Corp.2015442
+7K150547.decimal Astroid Dosimetry App.Decimal, Inc.20150—
+7K150045S30/S40 Digital Color Doppler Ultraound SystemSonoscape Company Limited201517—
+7K143668NavioBlue Belt Technologies, Inc.201520—
+7K143457NeuroBlate SystemMonteris Medical, Inc.201517Class I
+7K141369Visiq Diagnostic Ultra Sound SystemPhilips Ultrasound, Inc.20140—
+7K140187Ray StationRaysearch Laboratories AB2014191
+7K130387Orthoalign Plus SystemOrthalign, Inc.201331—
+7K122326Smarttools Knee SystemZimmer201232
+8K253856Geniant Cranial (Navigated Neurosurgical Positioning Robot)Koh Young Technology, Inc.20260—
+8K262315NeuroBlate SystemMonteris Medical20260—
+8K261882Pisces-SC Standalone Cervical Interbody SystemOsseus Fusions Systems, LLC20260—
+8K261205SPINEART Navigation Instrument SystemSpineart SA20260—
+8K262094E3D™-C Interbody SystemEvolution Spine20260—
+8K253050RadOncAIInformai20260—
+8K260036NeckTune™ 3D SA Cervical CageMedyssey Co, Ltd.20260—
+8K260582ROSA® Shoulder SystemOrthosoft Inc. (d/b/a) Zimmer CAS20260—
+8K260976NeuroBlate SystemMonteris Medical20261—
+8K254158SPINEART Navigation Instrument SystemSpineart SA20261—
+8K260546Q Pedicle InstrumentsK2m, Inc.20260—
+8K253391Visualase Cooled Laser Applicator System (9735559); Visualase Cooled Laser Applicator…Medtronic Navigation, Inc.20260—
+8K254105Hive™ Standalone Cervical System and Hive™ C Interbody SystemNanoHive Medical, LLC20260—
+8K252873Q Interbody InstrumentsK2m, Inc.20260—
+8K252871Spine Guidance 5.3 Software; Q Interbody Instruments; Elite Q Attachments; Elite Cutting…Stryker Leibinger GmbH & Co KG20261—
+8K260038E3D™-C Interbody SystemEvolution Spine20261—
+8K252755POINT Kinguide Agile Robotic Arm Surgical Stereotactic SystemPoint Robotics MedTech, Inc.20260—
+8K252847NextAR Hip PlatformMedacta International S.A.20260—
+8K252894aprevo® cervical interbody systemCarlsmed, Inc.20261—
+8K252841Real Intelligence™ Cori™ XT (Cori XT)Blue Belt Technologies, Inc.20250—
+8K251314Rosa® Knee SystemOrthosoft Inc. (d/b/a) Zimmer CAS20250—
+8K252476Viewer (5.4); Elements Viewer; Mixed Reality Viewer; Smart Layout; Elements Viewer Smart…Brainlab AG20250—
+8K251737NextAR (TM) Shoulder PlatformMedacta International S.A.20250—
+8K250064Dose+ (1.0)Mvision AI OY20250—
+8K251298Mobile Laser Unit (1001-N2); Thermoguide Workstation (1100-N1); Laser Applicator…Clinical Laserthermia Systems, AB20250—
+8K250108OptiVu™ ShoulderMr Surgical Solutions, LLC20251—
+8K242933SPINEART Navigation Instrument SystemSpineart SA20252—
+8K2432536600 Ultrasound System (MyLabA50); 6600 Ultrasound System (MyLabA70)Esaote, S.p.A.20252—
+8K250307Visualase V2 MRI-guided Laser Ablation System (9736422)Medtronic Navigation20251—
+8K2416716450 Ultrasound System (MyLabE80); 6450 Ultrasound System (MyLabE85)Esaote, S.p.A.20252—
+8K250030Flash Ultrasound System 5100 Point of CarePhilips Ultrasound, LLC202505
+8K242748OncospaceOncospace, Inc.20250—
+8K243802aprevo® anterior and lateral lumbar interbody fusion device, aprevo® anterior lumbar…Carlsmed, Inc.20253—
+8K242121mBôs (Monogram mBôs TKA System)Monogram Orthopaedics, Inc.20250—
+8K243387GYDER® Hip SystemGyder Surgical Pty, Ltd.20251—
+8K242264TMINI Miniature Robotic SystemTHINK Surgical, Inc.20247—
+8K233793CarboClear® X Pedicle Screw SystemCarboFix Orthopedics, Ltd.20241—
+8K240326Solar™ Lumbar Interbody Fusion SystemDegen Medical, Inc.20244—
+8K241171Spine Guidance Software (Version 5.1); Consolidated Operating Room Equipment (CORE) 2…Stryker Leibinger GmbH & Co KG20244—
+8K240846CarboClear® Hybrid Pedicle Screw System; CarboClear® Hybrid Navigated Instruments…CarboFix Orthopedics, Ltd.20242—
+8K234047Automatic RegistrationBrainlab AG20240—
+8K233944CarboClear® X Pedicle Screw System; CarboClear® X Navigated InstrumentsCarboFix Orthopedics, Ltd.20243—
+8K233154SkyOPS™ Orthopedic Plate SystemSky Surgical, LLC20231—
+8K231887ARIX Ankle Distal Tibia SystemJeil Medical Corporation20231—
+8K233227VELYS™ Robotic-Assisted SolutionDepuy Ireland UC20231—
+8K232521ExactechGPS® Total Ankle ApplicationBlue Ortho20230—
+8K232280NextAR™ TSA PlatformMedacta International S.A.20231—
+8K233292ISIS Headboxes, ISIS Neurostimulator, ISIS Xpert Plus, ISIS Xpert, ISIS XpressInomed Medizintechnik GmbH20231—
+8K231262Pangea Femur Plating System, Pangea Fibula Plating System, Pangea Tibia Plating System…Stryker GmbH20234—
+8K231257Pangea Utility Plating System, Pangea PlatformStryker GmbH20231—
+8K223553Spine Planning (2.0), Elements Spine Planning, Elements Planning SpineBrainlab AG20231—
+8K231103ROSA ONE Brain ApplicationMedtech S.A.S20230—
+8K230904Arthrex Virtual Implant Positioning (VIP) SystemArthrex, Inc.20231—
+8K223771Lumify Diagnostic Ultrasound SystemPhilips Ultrasound202322
+8K222381PeriPRO™ Femur System, Variable Angle Fixation System, AxSOS 3Ti, Stryker Plating SystemStryker GmbH20238—
+8K223804PercuNav Image Fusion and Interventional Navigation SystemPhilips Ultrasound, LLC20230—
+8K222966Cirq Arm System (2.0);Alignment System SpineBrainlab AG202201
+8K220169SonoMe Wireless Probe Type Ultrasound Scanner (Model: 5C, 5CB, H5C, 10L, 14L, 10LB…Bionet Co., Ltd.20220—
+8K213523X-CUBE i8, X-CUBE i9Alpinion Medical Systems Co., Ltd.20220—
+8K211987ATEC Alignment AppAlphatec Spine, Inc.20212—
+8K2120216430 MyLabX75, 6430 MyLab XPro75Esaote, S.p.A.20210—
+8K212297Omni Foot and Ankle Plating SystemExtremity Medical, LLC20211—
+8K201188Clear Guide SCENERGYClear Guide Medical20201—
+8K201898Clear Guide SCENERGYClear Guide Medical20200—
+8K201149CoLink Plating SystemIn2bones USA, LLC20200—
+8K193515Mako Total Knee ApplicationMako Surgical Corp.202016
+8K200449X-Cube 90Alpinion Medical Systems Co., Ltd.20204—
+8K200450X-Cube 70Alpinion Medical Systems Co., Ltd.20204—
+8K201633Terason uSmart 3200T Plus Ultrasound SystemTeratech Corporation20200—
+8K200888OMNIBotics Knee SystemCorin, Ltd.202011—
+8K201012EPIQ Diagnostic Ultrasound System Series, Affiniti Diagnostic Ultrasound System Series…Philips Ultrasound, Inc.2020185
+8K200339HS40 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20208—
+8K193128Mako Total Hip ApplicationMako Surgical Corp.20203—
+8K192080iASSIST Knee SystemOrthosoft Inc (D/B/A Zimmer Cas)20191—
+8K191007Aixplorer MACH 30, Aixplorer MACH 20 Ultrasound Diagnostic SystemsSupersonic Imagine20195—
+8K191369TSolution One Total Knee ApplicationTHINK Surgical, Inc.20195—
+8K192435NuVasive NuvaLineNu Vasive, Incorporated20190—
+8K192254InnoSight Diagnostic Ultrasound SystemQisda Corporation20190—
+8K191467Aplio i900/i800/i700/i600 Diagnostic Ultrasound System, V4.0Canon Medical Systems Corporation20199—