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
+7K231354Pocket Ultrasound System (C10)Beijing Konted Medical Technology Co.,Ltd20232—
+7K2301796440 MyLabX90Esaote, S.p.A.202341
+7K231494CoreLink Robotic Navigation InstrumentsCorelink, LLC20230—
+7K232500Lumify Diagnostic Ultrasound SystemPhilips Ultrasound202301
+7K232044Invictus Robotic Navigation InstrumentsAlphatec Spine, Inc.20233—
+7K230066Carnation series Diagnostic Ultrasound SystemShenzhen Wisonic Medical Technology Co., Ltd.20230—
+7K223558CUVIS-spineCurexo, Inc.20230—
+7K230202TMINI™ Miniature Robotic SystemTHINK Surgical, Inc.2023101
+7K223350Remi Robotic Navigation SystemFusion Robotics, LLC20230—
+7K221928ROSA® Knee SystemOrthosoft D/B/A Zimmer Cas20228—
+7K220733OptiVu ROSA MxROrthosoft Inc (D/B/A Zimmer Cas)20221—
+7K220862E-GPS Navigated InstrumentsPrecision Spine, Inc.20227—
+7K213873SkyWalker Total Knee SystemMicroport Navibot International, LLC20220—
+7K221028SURGIVISIO DeviceEcential Robotics20227—
+7K213708ROSA® Knee SystemOrthosoft Inc (D/B/A Zimmer Cas)20220—
+7K213454Midas Rex MR8 Depth Stop Attachment, Midas Rex MR8 Depth Stop Tool 2.4mm, Midas Rex MR8…Medtronic Powered Surgical Solutions20210—
+7K210989Cirq, Cirq Robotic Alignment System, Cirq Robotic Alignment Module Cranial, Cirq Robotic…Brainlab AG20212—
+7K211597EPIQ Series Diagnostic Ultrasound System, Affiniti Series Diagnostic Ultrasound SystemPhilips Medical Systems202117—
+7K211616ExcelsiusHubGlobus Medical, Inc.20219Class I
+7K210998ROSA Hip SystemOrthosoft D/B/A Zimmer Cas20211—
+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—
+7K201569CUVIS-spineCurexo, Inc.20212—
+7K210121ROSA Partial Knee SystemOrthosoft D/B/A Zimmer Cas20211—
+7K202184Practical Navigation Surgical Guidance System (PNSGS)Practical Navigation, LLC20215—
+7K203153CREO Stabilization System, Navigation Instruments, ExcelsiusGPSGlobus Medical, Inc.20211—
+7K202455Aixplorer®MACH20, Aixplorer®MACH30, Supersonic MACH40, Supersonic MACH30 & Supersoinc…Supersonic Imagine20200—
+7K202737Aplio i900/i800/i700/i600 Diagnostic Ultrasound System, Aplio a550, Aplio a450, and…Canon Medical Systems Corporation20200—
+7K201972Aplio i900/i800/i700 Diagnostic Ultrasound System, Software V5.1Canon Medical Systems Corporation20207—
+7K200047ExcelsiusGPS Cranial 1.0 ModuleGlobus Medical, Inc.202053
+7K200001MX7/ MX7T/ Vaus7/ Zeus Diagnostic Ultrasound System, ME7/ Anesus ME7/ Anesus ME7T…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20208—
+7K200339HS40 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20208—
+7K200304EPIQ Diagnostic Ultrasound SystemPhilips Ultrasound, Inc.2020243
+7K192170VistaScan USB Ultrasound Imaging SystemEmagine Solutions Technology, LLC20200—
+7K192410ZS3 and z.one pro Ultrasound SystemsShenzhen Mindray Bio-Medical Electronics Co., Ltd.20193—
+7K192152DC-80/DC-80 PRO/DC-80 EXP/DC-80S/DC-85/DC-86/DC-86S/DC-89/DC-TV/DC-TQ Diagnostic…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20196—
+7K1921576450 Ultrasound systemEsaote, S.p.A.20194—
+7K192573Dolphin Medical Imaging USB Ultrasound SystemDolphin Medical Imaging, LLC20190—
+7K192173ROSA ONE Spine applicationMedtech S.A20190—
+7K192133Zimmer Biomet Universal Navigation SystemZimmer Biomet Spine, Inc.20190—
+7K192226Lumify Diagnostic Ultrasound SystemPhilips Health Care2019315
+7K191100ExcelsiusGPS Spine 1.1 Interbody ModuleGlobus Medical, Inc.201942—
+7K190206DC-90/DC-90S/DC-90Q/DC-95/DC-95S/DC-88/DC-88S/DC-80A/DC-80A Exp/DC-80A…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20190—
+7K182417ROSA ONE Brain ApplicationMedtech S.A201913Class I
+7K183119SI-LOK® Sacroiliac Joint Fixation System, Navigation Instruments, ExcelsiusGPS®…Globus Medical, Inc.20192—
+7K182000AQrate Robotic Assistance SystemGlobus Medical, Inc.20191—
+7K182857EPIQ Diagnostic Ultrasound System, EPIQ 5 Diagnostic Ultrasound System, EPIQ 7…Philips Ultrasound, Inc.20181923
+7K182427Aplio a550 and a450, Software V2.8 Diagnostic Ultrasound SystemCanon Medical Systems Corporation20184—
+7K182679Aplio i900/i800/i700/i600 Diagnostic Ultrasound System, V3.1Canon Medical Systems Corporation201810—
+7K181313BenQ Diagnostic Ultrasound SystemQisda Corporation20181—
+7K181574UscanEchoNous, Inc.20180—
+7K173138Biim Diagnostic Ultrasound SystemBiim Ultrasound AS20170—
+7K170085SONON Ultrasound Imaging System, Model: 300LHealcerion Co., Ltd.20174—
+7K172385Clarius Ultrasound SystemClarius Mobile Health Corp.201722—
+7K163510Poseidon Ultrasound SystemButterfly Network, Inc.201762
+7K170303E5 Series Digital Color Doppler Ultrasound SystemSonoscape Medical Corp.20170—
+7K163427X3 Exp/X3/X3 Pro/X1 Pro/X1 Digital Color Doppler Ultrasound SystemSonoscape Medical Corp.20170—
+7K162288SonoSite iViz Ultrasound SystemFUJIFILM Sonosite, Inc.20163—
+7K160283S45 Digital Color Doppler Ultrasound SystemSonoscape Medical Corp.201615—
+8K260369Dynamis Robotic Surgical SystemLEM Surgical AG20260—
+8K261665CORUS™ Navigation System-GNProvidence Medical Technology, Inc.20260—
+8K253739SCRIPT™ Rods, CREO™ Stabilization System, REVERE® Stabilization System, REVERE® 4.5…Globus Medical, Inc.20260—
+8K252597Valence Robotic Navigation System; Valence Robotic Navigation Instruments (For Use with…Alphatec Spine, Inc.20261—
+8K252327CMORE® CT System; CMORE® CT System Navigated InstrumentsIcotec AG20251—
+8K250599ExcelsiusGPS™ InstrumentsGlobus Medical, Inc.20250—
+8K251820ViewMateTM Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.20250—
+8K251060CORUS™ Navigation System-GXProvidence Medical Technology, Inc.20250—
+8K2432536600 Ultrasound System (MyLabA50); 6600 Ultrasound System (MyLabA70)Esaote, S.p.A.20252—
+8K242575Stereotaxic Guiding Surgical Devices, NaoTrac SBrain Navi Biotechnology Co., Ltd.20250—
+8K2416716450 Ultrasound System (MyLabE80); 6450 Ultrasound System (MyLabE85)Esaote, S.p.A.20252—
+8K242519Lumify Diagnostic Ultrasound SystemPhilips Ultrasound20250Class I
+8K242670Lumify Diagnostic Ultrasound SystemPhilips Ultrasound20250Class I
+8K241979Pocket Ultrasound System (C10, C10TX, C10RL, C10RLpro)Beijing Konted Medical Technology Co.,Ltd20241—
+8K233256Robotic Integration InstrumentsDePuy Synthes20240—
+8K233228Spine Navigation and Robotic-Assistance DeviceEcential Robotics202421
+8K233788EPIQ Series Diagnostic Ultrasound System, Affiniti Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC2024161
+8K231923Liberty SI Lateral Implant SystemSpinal Simplicity, LLC20230—
+8K232533ROSA Partial Knee SystemOrthosoft D/B/A Zimmer Cas20230—
+8K232802TMINI™ Miniature Robotic SystemTHINK Surgical, Inc.20239—
+8K231886SURGIVISIO DeviceEcential Robotics20236—
+8K230567OptiVu™ ROSA® MxROrthosoft Inc (D/B/A Zimmer Cas)20230—
+8K230768M9/M9CV/M9T/M8 Elite/M10/M10CV/Crius M10/M11/M11CV/Crius M11/Operus M11/M9 Premium…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20231—
+8K231162ROSA Hip SystemOrthosoft Inc (D/B/A Zimmer Cas)20230—
+8K230243ROSA® Knee SystemOrthosoft D/B/A Zimmer Cas20236—
+8K230180Rosa Knee SystemOrthosoft Inc (D/B/A Zimmer Cas)20230—
+8K222754ViewMate Multi Ultrasound SystemShenzhen Mindray Bio-Meidcal Electronics Co., Ltd.20221—
+8K223070Remi Robotic Navigation SystemFusion Robotics, LLC20224—
+8K222191Aixplorer MACH30 / SUPERSONIC MACH30, Aixplorer MACH20 / SUPERSONIC , MACH20, SUPERSONIC…Supersonic Imagine20221—
+8K222270HEDRON Cervical Spacers, HEDRON Lumbar Spacers, SABLE Expandable Spacer, ExcelsiusGPS…Globus Medical, Inc.202223—
+8K221093X-Cube 70, X-Cube 90Alpinion Medical Systems Co., Ltd.20220—
+8K220857X-Cube 50, X-Cube 60Alpinion Medical Systems Co., Ltd.20221—
+8K222698CUVIS-spineCurexo, Inc.20220—
+8K2226485000 Compact Series Ultrasound Systems (Ultrasound System 5500 G, Ultrasound System 5500…Philips Ultrasound, LLC202212
+8K213862HD60 Series Ultrasound Diagnostic SystemQingdao Hisense Medical Equipment Co., Ltd.20223—
+8K212400SONON Ultrasound Imaging System, Model: SONON 500LHealcerion Co., Ltd.20220—
+8K212962TRELLIS™ SI Joint Fusion SystemOrthofundamentals, LLC20220—
+8K212333Aplio i900/i800/i700 Diagnostic Ultrasound System, Software V6.5Canon Medical Systems Corporation202261
+8K212900MX7/MX7T/Vaus7/Zeus/ME7/Anesus ME7/Anesus ME7T/MX8/MX8T/Vaus8/ME8 Diagnostic Ultrasound…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20217—