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
+8K202406Butterfly iQ Ultrasound SystemButterfly Network, Inc.20205—
+8K202216EPIQ Series Diagnostic Ultrasound SystemsPhilips Ultrasound, Inc.2020218
+8K201693DC-90/DC-90S/DC-90Q/DC-95/DC-95S/DC-88/DC-88S/DC-80A/DC-80AExp/DC-80A…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20201—
+8K193515Mako Total Knee ApplicationMako Surgical Corp.202016
+8K200888OMNIBotics Knee SystemCorin, Ltd.202011—
+8K191235Leltek Ultrasound Imaging SystemLeltek, Inc.20209—
+8K193128Mako Total Hip ApplicationMako Surgical Corp.20203—
+8K192080iASSIST Knee SystemOrthosoft Inc (D/B/A Zimmer Cas)20191—
+8K191369TSolution One Total Knee ApplicationTHINK Surgical, Inc.20195—
+8K191663Aplio a550, Aplio a450 and Aplio a, Diagnostic Ultrasound System, V4.0Canon Medical Systems Corporation20193—
+8K180799Clarius Ultrasound ScannerClarius Mobile Health Corp.201811—
+8K180277Smith & Nephew SURESHOT Distal Targeting System V4.0 TargeterSmith & Nephew, Inc.20180—
+8K180704SonoSite iViz Ultrasound SystemFUJIFILM Sonosite, Inc.20182—
+8K172082S60 Series Digital Color Doppler Ultrasound SystemSonoscape Medical Corp.20175—
+8K170999P50 Series Digital Color Doppler Ultrasound SystemSonoscape Medical Corp.20174—
+8K171000P60 Series Digital Color Doppler Ultrasound SystemSonoscape Medical Corp.20174—
+8K170891Mako Partial Knee ApplicationMako Surgical Corp.201723
+8K170581Mako Total Knee ApplicationMako Surgical Corp.2017381
+8K170280Smith & Nephew SURESHOT Distal Targeting System V4.0Smith & Nephew, Inc.20170—
+8K152574NavioBlue Belt Technologies, Inc.201519—
+8K141601Iassist Knee SystemZimmer Cas20142—
+8K130748Smith & Nephew Sureshot Distal Targeting System V3.0Smith & Nephew, Inc.20131—
+8K110670VLP Foot Talus Plates, VLP Percutaneous Calcaneus Plates and Misc VLP Bone Screws…Smith & Nephew, Inc.201169—
+8K110240Smith & Nephew, Inc. Sureshot Distal Targeting System V2.1Smith & Nephew, Inc.20112—
+8K102967Smith & Nephew, Inc. Sureshot Distal Targeting System V2.0.2Smith & Newphew, Inc.20103—
+8K100107Smith & Nephew Sureshot Distal Targeting System V2.0Smith & Nephew, Inc.2010751
+9K261205SPINEART Navigation Instrument SystemSpineart SA20260—
+9K261081Pocket Ultrasound System (C10MTpro,C10MXpro,C10MSpro,C10MBpro,C10MRpro)Beijing Konted Medical Technology Co.,Ltd20260—
+9K260480VELYS™ Robotic-Assisted SolutionDepuy Ireland UC20260—
+9K260582ROSA® Shoulder SystemOrthosoft Inc. (d/b/a) Zimmer CAS20260—
+9K2532886450 Ultrasound System (MyLabE80); 6450 Ultrasound System (MyLabE85)Esaote, S.p.A.20260—
+9K252037CUVIS-joint (CJ150)Curexo, Inc.20260—
+9K260595Sonosite iLOOK Ultrasound SystemFUJIFILM Sonosite, Inc.20260—
+9K253623Spine Guidance 5.4 Software; Spine Guidance 5.4 Upgrade; Spine Guidance 5.4 Update…Stryker Leibinger GmbH & Co KG20260—
+9K251268Diagnostic Ultrasound System (Nano C5, Nano C5 EXP, Nano L12, and Nano L12 EXP)Edan Instruments, Inc.20250—
+9K2533107600 Ultrasound System (MyLabC25); 7600 Ultrasound System (MyLabC30)Esaote, S.p.A.20250—
+9K251250ViewMate™ Multi Ultrasound System (VMM-ICE-01); ViewMate™ Multi Ultrasound System…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20250—
+9K252170OptiVu™ ShoulderMr Surgical Solutions, LLC20250—
+9K250228eHertz Functional Series Diagnostic Ultrasound System (eHertz C, eHertz E, eHertz R…Esonic Technology (Wuhan) Co., Ltd.20250—
+9K243958Consolidated Operating Room Equipment (CORE) 2 ConsoleStryker Instruments20250—
+9K243751Mako Total Hip Application 5.0Mako Surgical Corp.20251—
+9K241949Digital Color Doppler Ultrasound System (P60 Series)Sonoscape Medical Corp.20250—
+9K242800The 5000 Compact Series Ultrasound SystemsPhilips Ultrasound, LLC20240—
+9K243106CarboClear® Hybrid Pedicle Screw SystemCarboFix Orthopedics, Ltd.20240—
+9K240980EPIQ Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC20240—
+9K241097Arthrex Virtual Implant Positioning (VIP) System SoftwareArthrex, Inc.20240—
+9K242223SuperSonic HepaVuSupersonic Imagine20240—
+9K241432MX7/MX7T/Vaus7/Zeus/ME7/Anesus ME7/Anesus ME7T/MX7P/MX7W/MX8/MX8T/Vaus8/ME8 Diagnostic…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20241—
+9K241517Q Guidance System; Mako Spine System;Stryker Leibinger GmbH & Co KG20242—
+9K233579SC1 Handheld Ultrasound Imaging system (Model: SC1)Fcu Co., Ltd.20240—
+9K233841HD80 Series Ultrasound Diagnostic SystemQingdao Hisense Medical Equipment Co., Ltd.20240—
+9K232908Color Doppler Ultrasound Diagnostic System (CMS1700B), Color Doppler Ultrasound…Contec Medical Systems Co.,Ltd20240—
+9K240850EPIQ Series Diagnostic Ultrasound Systems; Affiniti Series Diagnostic Ultrasound SystemsPhilips Ultrasound, LLC202414—
+9K233439HD60 Series Ultrasound Diagnostic SystemQingdao Hisense Medical Equipment Co., Ltd.20240—
+9K231659MS55 Plus Digital Color Doppler Ultrasound System (MS55); P25 Expert Digital Color…Medisono20240—
+9K232533ROSA Partial Knee SystemOrthosoft D/B/A Zimmer Cas20230—
+9K231172ApolloKneeCorin U.S.A. Limited20230—
+9K223564X-Cube 50, X-Cube 60Alpinion Medical Systems Co., Ltd.20230—
+9K220068Butterfly iQ/iQ+ Ultrasound SystemButterfly Network, Inc.20232—
+9K223017Aplio i900/i800/i700 Diagnostic Ultrasound System, Software V7.0Canon Medical Systems Corporation20235—
+9K220774RobPath® Total Hip ApplicationHangzhou Lancet Robotics Co., Ltd.20220—
+9K213126Smith & Nephew, Inc. Plates and Screws Systems: EVOS, Peri-Loc, D-Rad, TC-100, VLP…Smith & Nephew, Inc.202221
+9K221496Consona N6, Consona N6 Pro, Consona N6 Super, Consona AR, Consona N6S, Consona AE…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20220—
+9K221300Consona N9, Consona N9 Pro, Consona N9 Super, Consona Nova, Consona N9S, Consona NI…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20223—
+9K221089P12 Elite Series Digital Color Doppler Ultrasound SystemSonoscape Medical Corp.20220—
+9K221140P20 Elite Series Digital Color Doppler Ultrasound SystemSonoscape Medical Corp.20220—
+9K221599HS40 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20220—
+9K221224Real Intelligence CoriBlue Belt Technologies, Inc.20229—
+9K220269HM70 EVO Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20223—
+9K213033iASSIST Knee SystemOrthosoft D/B/A Zimmer Cas20220—
+9K210432LELTEK Ultrasound Imaging System (Model: LU700 Series)Leltek, Inc.20218—
+9K212704Philips EPIQ Diagnostic Ultrasound System, Philips Affiniti Diagnostic Ultrasound SystemPhilips Medical Systems20212—
+9K211527Exo IrisExo Imaging, Inc.20211—
+9K211337DC-70/DC-70T/DC-70 Pro/DC-70 Exp/DC-75/DC-78/DC-70S Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.20210—
+9K210837Smith & Nephew Plates and ScrewsSmith & Nephew, Inc.202171
+9K202364Aplio a550, Aplio a450, Aplio a, Diagnostic Ultrasound System, Software V5.1Canon Medical Systems Corporation20201—
+9K202160Sonosite PX Ultrasound System, Sonosite SII Ultrasound System, Sonosite iViz Ultrasound…FUJIFILM Sonosite, Inc.20200—
+9K201059S60 Elite Series/S70 Series Digital Color Doppler Ultrasound SystemSonoscape Medical Corp.20204—
+9K201255TSolution® One Total Knee ApplicationTHINK Surgical, Inc.20203—
+9K193135TSolution One Total Knee ApplicationTHINK Surgical, Inc.20194—
+9K192107Clarius Ultrasound ScannerClarius Mobile Health Corp.201910—
+9K172993P20 Series Digital Color Doppler Ultrasound SystemSonoscape Medical Corp.20171—
+9K173058P10 Series Digital Color Doppler Ultrasound SystemSonoscape Medical Corp.20171—
+9K172301Mako Partial Knee ApplicationMako Surgical Corp.201716
+9K172219Mako Total Knee ApplicationMako Surgical Corp.201737—
+9K170977SURESHOT Distal Targeting System V4.0 Trauma InterfaceSmith & Nephew, Inc.20170—
+9K160537NavioBlue Belt Technologies, Inc.201618—
+9K152976VLP Mini-Mod Talus PlatesSmith & Nephew, Inc.20158—
+9K140792Salvation 3DI Plating SystemWrightmedicaltechnologyinc201421
+9K140408Salvation Osteopenic ScrewWrightmedicaltechnologyinc20141—
+9K133930Flower Rear Foot Plating Set, Flower Calcaneus Planting Set, Flower Rearfoot Plating SetFlower Orthopedics Corporation201406
+9K123347Normed Ankle Fix System 4.0 and Normed Ankle Fix Plus System 4.0Normed Medizin-Technik GmbH201322
+9K121425Ortholoc 3DI Ankle Fusion Plating SystemWrightmedicaltechnologyinc201253—
+9K120667VLP 2.7MM Extra Large Percutaneous Calcaneus Plate, Peri-Loc 3.5MM Anterior Ankle Fusion…Smith & Nephew, Inc.20129—
+10K260274Airlock® Ankle Plating SystemNovastep SAS20260—
+10K253713Arthrex Variable Angle (VA) Proximal Tibia Plating SystemArthrex, Inc.20260—
+10K251853Consona N5, Consona N5 Pro, Consona N5 Super, Consona N5 Exp, Consona ER, Consona N5S…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20251—
+10K252019CurvaFix Low Profile SystemCurvafix, Inc.20250—
+10K251192Diagnostic Ultrasound System (MX7); Diagnostic Ultrasound System (MX7T); Diagnostic…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20250—
+10K251455EPIQ Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC20250—