510(k) Report

Devices descending from K010968

225 later devices reach Vectorvision CT/Fluoro through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K131278Monteris Medical Neuroblate SystemMonteris Medical, Inc.2013191
+5K120812RenaissanceMazor Robotics, Ltd.2012211
+5K121384MylabsognoEsaote, S.p.A.201211
+5K113228Renaissance SystemMazor Robotics, Ltd.201123—
+5K111302Mylabseven, MylabalphaEsaote, S.p.A.201124—
+5K110688MylabgoldEsaote2011251
+6K254158SPINEART Navigation Instrument SystemSpineart SA20261—
+6K252755POINT Kinguide Agile Robotic Arm Surgical Stereotactic SystemPoint Robotics MedTech, Inc.20260—
+6K252847NextAR Hip PlatformMedacta International S.A.20260—
+6K252841Real Intelligence™ Cori™ XT (Cori XT)Blue Belt Technologies, Inc.20250—
+6K251737NextAR (TM) Shoulder PlatformMedacta International S.A.20250—
+6K250108OptiVu™ ShoulderMr Surgical Solutions, LLC20251—
+6K242933SPINEART Navigation Instrument SystemSpineart SA20252—
+6K250086OTS HipOrtoma AB202511
+6K233793CarboClear® X Pedicle Screw SystemCarboFix Orthopedics, Ltd.20241—
+6K240721ExcelsiusFlex™Globus Medical, Inc.20240—
+6K240662Spine Guidance Software (version 5.0); Xia 3/ Serrato Q Instruments; Everest Q…Stryker Leibinger GmbH & Co KG20247—
+6K240877Monteris Medical NeuroBlate SystemMonteris Medical,20245—
+6K240846CarboClear® Hybrid Pedicle Screw System; CarboClear® Hybrid Navigated Instruments…CarboFix Orthopedics, Ltd.20242—
+6K234047Automatic RegistrationBrainlab AG20240—
+6K233199ROSA® Shoulder SystemOrthosoft Inc (D/B/A Zimmer Cas)20243—
+6K233944CarboClear® X Pedicle Screw System; CarboClear® X Navigated InstrumentsCarboFix Orthopedics, Ltd.20243—
+6K233227VELYS™ Robotic-Assisted SolutionDepuy Ireland UC20231—
+6K232521ExactechGPS® Total Ankle ApplicationBlue Ortho20230—
+6K232280NextAR™ TSA PlatformMedacta International S.A.20231—
+6K230045HipCheckStryker Corp.20230—
+6K223553Spine Planning (2.0), Elements Spine Planning, Elements Planning SpineBrainlab AG20231—
+6K230904Arthrex Virtual Implant Positioning (VIP) SystemArthrex, Inc.20231—
+6K222983NeuroBlate Fusion-S Software V3.17Monteris Medical,20237—
+6K222966Cirq Arm System (2.0);Alignment System SpineBrainlab AG202201
+6K211269Visualase MRI-Guided Laser Ablation System (SW 3.4)Medtronic Navigation, Inc.202271
+6K200888OMNIBotics Knee SystemCorin, Ltd.202011—
+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—
+6K1831916420 Ultrasound SystemEsaote, S.p.A.20180—
+6K181848ADAPT for Gamma3, Gamma3Stryker GmbH20181—
+6K171255Monteris Medical NeuroBlate SystemMonteris Medical, Inc.201714Class I
+6K171105AIXPLORER® & AIXPLORER® Ultimate Ultrasound SystemsSupersonic Imagine201719—
+6K163119NaviSuite SSI EditionMedcom GmbH20171—
+6K1630826200 Ultrasound System and 6250 Ultrasound SystemEsaote, S.p.A.201792
+6K162290MyLabSix CrystaLineEsaote, S.p.A.20160—
+6K152041Renaissance X SystemMazor Robotics, Ltd.201520—
+6K143457NeuroBlate SystemMonteris Medical, Inc.201517Class I
+6K142077MylabgammaEsaote, S.p.A.201453
+6K140167Renaissance X SystemMazor Robotics, Ltd.201421—
+6K141486Mylabsix Ultrasound SystemEsaote Europe B.V.20148—
+7K262315NeuroBlate SystemMonteris Medical20260—
+7K261205SPINEART Navigation Instrument SystemSpineart SA20260—
+7K261852OTS HipOrtoma AB20260—
+7K260480VELYS™ Robotic-Assisted SolutionDepuy Ireland UC20260—
+7K260582ROSA® Shoulder SystemOrthosoft Inc. (d/b/a) Zimmer CAS20260—
+7K260976NeuroBlate SystemMonteris Medical20261—
+7K260546Q Pedicle InstrumentsK2m, Inc.20260—
+7K253391Visualase Cooled Laser Applicator System (9735559); Visualase Cooled Laser Applicator…Medtronic Navigation, Inc.20260—
+7K252873Q Interbody InstrumentsK2m, Inc.20260—
+7K252871Spine Guidance 5.3 Software; Q Interbody Instruments; Elite Q Attachments; Elite Cutting…Stryker Leibinger GmbH & Co KG20261—
+7K251298Mobile Laser Unit (1001-N2); Thermoguide Workstation (1100-N1); Laser Applicator…Clinical Laserthermia Systems, AB20250—
+7K252170OptiVu™ ShoulderMr Surgical Solutions, LLC20250—
+7K250307Visualase V2 MRI-guided Laser Ablation System (9736422)Medtronic Navigation20251—
+7K243106CarboClear® Hybrid Pedicle Screw SystemCarboFix Orthopedics, Ltd.20240—
+7K241097Arthrex Virtual Implant Positioning (VIP) System SoftwareArthrex, Inc.20240—
+7K241171Spine Guidance Software (Version 5.1); Consolidated Operating Room Equipment (CORE) 2…Stryker Leibinger GmbH & Co KG20244—
+7K231172ApolloKneeCorin U.S.A. Limited20230—
+7K221224Real Intelligence CoriBlue Belt Technologies, Inc.20229—
+7K202749ADAPT for Gamma3Stryker GmbH20200—
+7K1732916440 Ultrasound SystemEsaote, S.p.A.20188—
+7K173021Aixplorer & Aixplorer Ultimate Ultrasound Diagnostic SystemsSupersonic Imagine201818—
+7K170841BiopSee, Mobile USMedcom GmbH20170—
+7K163221Mazor XMazor Robotics, Ltd.201719—
+8K253623Spine Guidance 5.4 Software; Spine Guidance 5.4 Upgrade; Spine Guidance 5.4 Update…Stryker Leibinger GmbH & Co KG20260—
+8K243958Consolidated Operating Room Equipment (CORE) 2 ConsoleStryker Instruments20250—
+8K241517Q Guidance System; Mako Spine System;Stryker Leibinger GmbH & Co KG20242—
+8K240113CORIOGRAPH Knee Pre-Op PlanSmith & Nephew, Inc.20242—
+8K2301796440 MyLabX90Esaote, S.p.A.202341
+8K231963Real Intelligence™ Cori™Blue Belt Technologies, Inc.202342
+8K230876RI.KNEE Adjustable Tibia Cut GuideEnztec Limited20230—
+8K200655FibroScan® 630Echosens20200—
+8K1921576450 Ultrasound systemEsaote, S.p.A.20194—
+8K180572AIXPLORER MACH Ultrasound Diagnostic Systems Aixplorer Mach 30, Aixplorer Mach 20…Supersonic Imagine201816—
+8K180307Mazor XMazor Robotics, Ltd.201817—
+8K172522Mazor XMazor Robotics, Ltd.20170—
+9K2432536600 Ultrasound System (MyLabA50); 6600 Ultrasound System (MyLabA70)Esaote, S.p.A.20252—
+9K2416716450 Ultrasound System (MyLabE80); 6450 Ultrasound System (MyLabE85)Esaote, S.p.A.20252—
+9K242272CORIOGRAPH Pre-Op Planning and Modeling ServicesBlue Belt Technologies, Inc.20241—
+9K240139Real Intelligence™ CORI™Blue Belt Technologies, Inc.202431
+9K2120216430 MyLabX75, 6430 MyLab XPro75Esaote, S.p.A.20210—
+9K191007Aixplorer MACH 30, Aixplorer MACH 20 Ultrasound Diagnostic SystemsSupersonic Imagine20195—
+9K191467Aplio i900/i800/i700/i600 Diagnostic Ultrasound System, V4.0Canon Medical Systems Corporation20199—
+9K182077Mazor X System (Mazor X Stealth Edition)Mazor Robotics, Ltd.2018162
+10K261272ePascal S/ ePascal SOR/ ePascal S5/ ePascal SA/ ePascal SE/ ePascal 80Elite/ ePascal 80/…Esonic Technology (Wuhan) Co., Ltd.20260—
+10K2532886450 Ultrasound System (MyLabE80); 6450 Ultrasound System (MyLabE85)Esaote, S.p.A.20260—
+10K260601Real Intelligence™ Cori™Blue Belt Technologies, Inc.20260—
+10K2533107600 Ultrasound System (MyLabC25); 7600 Ultrasound System (MyLabC30)Esaote, S.p.A.20250—
+10K251971RPS Primary TKA Software; RPS Console; RPS Saw One; RPS Cable; RPS Saw Oscillating Tip…Stryker Instruments20250—
+10K250921CORIOGRAPH Pre-Op Planning and Modeling ServicesBlue Belt Technologies, Inc.20250—
+10K203645Aixplorer MACH30/ SUPERSONIC MACH30, Aixplorer MACH20/ SUPERSONIC MACH20, SUPERSONIC…Supersonic Imagine20212—
+10K202455Aixplorer®MACH20, Aixplorer®MACH30, Supersonic MACH40, Supersonic MACH30 & Supersoinc…Supersonic Imagine20200—
+10K202737Aplio i900/i800/i700/i600 Diagnostic Ultrasound System, Aplio a550, Aplio a450, and…Canon Medical Systems Corporation20200—
+10K201972Aplio i900/i800/i700 Diagnostic Ultrasound System, Software V5.1Canon Medical Systems Corporation20207—