510(k) Report

Devices descending from K022126

463 later devices reach Catheter Introducer for the Stealthstation System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K182594E-CUBE i7Alpinion Medical Systems Co., Ltd.20191—
+5K182894HM70A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201910—
+5K1831916420 Ultrasound SystemEsaote, S.p.A.20180—
+5K181617E-CUBE 8Alpinion Medical Systems Co., Ltd.20180—
+5K181277E-CUBE 12Alpinion Medical Systems Co., Ltd.20187—
+5K180572AIXPLORER MACH Ultrasound Diagnostic Systems Aixplorer Mach 30, Aixplorer Mach 20…Supersonic Imagine201816—
+5K173021Aixplorer & Aixplorer Ultimate Ultrasound Diagnostic SystemsSupersonic Imagine201818—
+5K172732E-CUBE 8Alpinion Medical Systems Co., Ltd.201711—
+5K171677Clear Guide SCENERGYClear Guide Medical20173—
+5K171926C5 Diagnostic Ultrasound SystemGuangzhou Sonostar Technologies Co., Ltd.20171—
+5K172607Philips EPIQ 5 Diagnostic Ultrasound System, EPIQ 7 Diagnostic Ultrasound System…Philips Health Care20172831
+5K172522Mazor XMazor Robotics, Ltd.20170—
+5K172055DUS-7000 Digital Color Doppler Ultrasound SystemAdvanced Instrumentations, Inc.20170—
+5K163702Aplio i900/i800/i700 Diagnostic Ultrasound System, V2.1Toshibamedical Systems Corporation2017221
+5K170078Medisono Color Doppler Ultrasound System, models P11 Portable, P11 EXPERT Portable, P12…Medisono, LLC20170—
+5K163119NaviSuite SSI EditionMedcom GmbH20171—
+5K163690DC-70/DC-70T /DC-70 Pro/DC-70 Exp/DC-75/DC-78/DC-70S Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.20179—
+5K170277DC-8/DC-8 PRO/DC-8 CV/DC-8 EXP/DC-8S Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.201720—
+5K1630826200 Ultrasound System and 6250 Ultrasound SystemEsaote, S.p.A.201792
+5K163020Xperius Ultrasound SystemPhilips Health Care201611
+5K162290MyLabSix CrystaLineEsaote, S.p.A.20160—
+5K161439E-CUBE 11Alpinion Medical Systems Co., Ltd.201612—
+5K161843Aplio i900/i800/i700 Diagnostic Ultrasound System, V2.0Toshibamedical Systems Corporation2016231
+5K162329CX50 Diagnostic Ultrasound System, Sparq Diagnostic Ultrasound SystemPhilips Health Care2016273
+5K153424E-CUBE i7Alpinion Medical Systems Co., Ltd.201614—
+5K151511ROSA SpineMedtech S.A20161093
+5K151359ROSA BrainMedtech S.A201520Class I
+5K152983FUJIFILM SonoSite iViz Ultrasound SystemFUJIFILM Sonosite, Inc.20155—
+5K143420SYMBIS Surgical SystemImris, Inc.20150—
+5K152899Philips Lumify Diagnostic Ultrasound SystemPhilips Healthcare, Inc.2015794
+5K152396S12 Digital Color Doppler Ultrasound SystemSonoscape Medical Corp.20151—
+5K152164S8 Exp/S9 Pro Portable Digital Color Doppler Ultrasound SystemSonoscape Medical Corp.20153—
+5K152165S9 Portable Digital Color Doppler Ultrasound SystemSonoscape Medical Corp.201502
+5K150045S30/S40 Digital Color Doppler Ultraound SystemSonoscape Company Limited201517—
+5K142077MylabgammaEsaote, S.p.A.201453
+5K141486Mylabsix Ultrasound SystemEsaote Europe B.V.20148—
+5K141369Visiq Diagnostic Ultra Sound SystemPhilips Ultrasound, Inc.20140—
+6K250030Flash Ultrasound System 5100 Point of CarePhilips Ultrasound, LLC202505
+6K243698Alignment System Cranial, with Alignment Software Cranial with LITT; Cirq Alignment…Brainlab AG20250—
+6K223771Lumify Diagnostic Ultrasound SystemPhilips Ultrasound202322
+6K223804PercuNav Image Fusion and Interventional Navigation SystemPhilips Ultrasound, LLC20230—
+6K221911Vinno 6PRO, Vinno 6EXP, Vinno 5PRO, Vinno 5EXP, Vinno 3, Vinno 3PRO, Vinno 3EXPVinno Technology (Suzhou) Co.,Ltd20220—
+6K220169SonoMe Wireless Probe Type Ultrasound Scanner (Model: 5C, 5CB, H5C, 10L, 14L, 10LB…Bionet Co., Ltd.20220—
+6K221098Scopis ENT Software, Scopis ENT Software with TGS, Scopis Planning Software…Stryker Corporation202201
+6K213523X-CUBE i8, X-CUBE i9Alpinion Medical Systems Co., Ltd.20220—
+6K201188Clear Guide SCENERGYClear Guide Medical20201—
+6K201898Clear Guide SCENERGYClear Guide Medical20200—
+6K200655FibroScan® 630Echosens20200—
+6K200449X-Cube 90Alpinion Medical Systems Co., Ltd.20204—
+6K200450X-Cube 70Alpinion Medical Systems Co., Ltd.20204—
+6K201633Terason uSmart 3200T Plus Ultrasound SystemTeratech Corporation20200—
+6K201012EPIQ Diagnostic Ultrasound System Series, Affiniti Diagnostic Ultrasound System Series…Philips Ultrasound, Inc.2020185
+6K191597Stealth Autoguide System, Midas Rex Legend Depth Stop SystemMedtronic Navigation, Inc.201941
+6K191007Aixplorer MACH 30, Aixplorer MACH 20 Ultrasound Diagnostic SystemsSupersonic Imagine20195—
+6K192254InnoSight Diagnostic Ultrasound SystemQisda Corporation20190—
+6K191467Aplio i900/i800/i700/i600 Diagnostic Ultrasound System, V4.0Canon Medical Systems Corporation20199—
+6K191055HS40 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20199—
+6K182848ROSA ONE Spine applicationMedtech S.A201910—
+6K182964ROSA Knee SystemOrthosoft Inc (D/B/A Zimmer Cas)201929—
+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—
+6K182529Xperius Ultrasound SystemPhilips Ultrasound, Inc.20180—
+6K181485EPIQ , EPIQ 5, EPIQ 7, Affiniti 30, Affiniti 50 and Affiniti 70 Diagnostic Ultrasound…Philips Ultrasound, Inc.20182724
+6K172444ROSA BRAIN (v3.0.0.5)Medtech S.A201814Class I
+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—
+6K171891ZS3 Ultrasound System, z.one pro Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.20174—
+6K171651Excelsius GPSGlobus Medical, Inc.2017691
+6K170841BiopSee, Mobile USMedcom GmbH20170—
+6K171034M9 Diagnostic Ultrasound System, M9T Diagnostic Ultrasound System, M9CV Diagnostic…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.201712—
+6K163443Interson USB Ultrasound SystemInterson Corporation20173—
+6K163138Clarius Ultrasound SystemClarius Mobile Health Corp.201628—
+6K162549Lumify Ultrasound SystemPhilips Health Care2016436
+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—
+7K262067iFuse Granite Onyx™ Implant SystemSI-BONE, Inc.20260—
+7K261272ePascal S/ ePascal SOR/ ePascal S5/ ePascal SA/ ePascal SE/ ePascal 80Elite/ ePascal 80/…Esonic Technology (Wuhan) Co., Ltd.20260—
+7K252558Lumify Diagnostic Ultrasound SystemPhilips Ultrasound, LLC20260—
+7K254148VERTICALE GPS InstrumentsSilony Medical GmbH20260—
+7K252058ROSA Knee System with UltraSound Imaging Platform (USIP)Balmoral Medical, LLC20260—
+7K252557Lumify Diagnostic Ultrasound SystemPhilips Ultrasound, LLC20250—
+7K251780iGPS Navigation InstrumentsSI-BONE, Inc.20250—
+7K251073Innovasis Navigation Instruments (Vector G-E Navigation Instruments and the Excella G-E…Innovasis, Inc.202501
+7K241525ExcelsiusXR™Globus Medical, Inc.20250—
+7K243326Dynamis Robotic Surgical SystemLEM Surgical AG20251—
+7K243514Salvo® Robotic Navigation InstrumentsSpine Wave, Inc.20250—
+7K243814NuVasive Pulse SystemGlobus Medical, Inc.20250—
+7K243671ExcelsiusGPS® InstrumentsGlobus Medical, Inc.20240—
+7K240160EGPS Navigated InstrumentsAstura Medical20240—
+7K240721ExcelsiusFlex™Globus Medical, Inc.20240—
+7K240951Invictus Robotic Navigation InstrumentsAlphatec Spine20242—
+7K240568DuraPro™ Oscillating SystemGlobus Medical, Inc.20240—
+7K231850QUARTEX® Occipito-Cervico-Thoracic Spinal System ExcelsiusGPS® InstrumentsGlobus Medical, Inc.20242—
+7K233638VERZA™ High Speed DrillsGlobus Medical, Inc.20241—
+7K234030Clear Guide SCENERGYClear Guide Medical20240—
+7K233734Interson USB Ultrasound SystemInterson Corporation20230—