510(k) Report

Devices descending from K954276

549 later devices reach Stealthstation through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K171309BR-FHUS Navigation 1.0Taihao Medical, Inc.20171—
+4K171661Scopis Extended Instrument Set EMScopis GmbH20173—
+4K171105AIXPLORER® & AIXPLORER® Ultimate Ultrasound SystemsSupersonic Imagine201719—
+4K162719iTotal® Hip Replacement SystemConformis, Inc.2017174
+4K170716PercuNav Image Fusion and Interventional NavigationPhilips Ultrasound, Inc.20173—
+4K163416Fiagon Navigation – PointerTube Straight and PointerTube KeatFiagon GmbH20170—
+4K163120EPIQ 5 Diagnostic Ultrasound System; EPIQ 7 Diagnostic Ultrasound System; Affiniti 50…Philips Ultrasound, Inc.20175828
+4K161697Acclarent NavWire Sinus Navigation GuidewireAcclarent, Inc.20163—
+4K152893Corin Optimized Positioning System (OPS)Corin USA20168—
+4K160807EPIQ 5 Diagnostic Ultrasound System, EPIQ 7Diagnostic Ultrasound System, Affiniti 50…Philips Ultrasound, Inc.201610033
+4K160479PointerShell Universal, PointerShell LSFiagon GmbH20160—
+4K160369GuideWireFiagon GmbH20163—
+4K153004Clear Guide SCENERGYClear Guide Medical20164—
+4K153480ClearVue850 Diagnostic Ultrasound SystemPhilips Health Care2015210
+4K152761Permanent Beacon Transponder, Soft Tissue Beacon Transponder, Beacon Care Package - Soft…Varian Medical Systems, Inc.20150—
+4K150780Acetabular Cup Orientation SystemMaterialise NV20150—
+4K150773E-CUBE 15 Diagnostic Ultrasound SystemAlpinion Medical Systems Co., Ltd.201515—
+4K151451Aplio 500/400/300 Diagnostic Ultrasound System V6.0Toshibamedical Systems Corporation2015342
+4K150533Terason uSmart3200T Ultrasound SystemTeratech Corp.20152—
+4K150148Terason uSmart3300 Ultrasound SystemTeratech Corp.20150—
+4K142714S8 Exp/S9 Pro Portable Digital Color Doppler Ultrasound SystemSonoscape Company Limited20154—
+4K142815S22 Digital Color Doppler Ultrasound SystemSonoscape Company Limited20152—
+4K142710S9 Portable Digital Color Doppler Ultrasound SystemSonoscape Company Limited201519—
+4K142474S12 Digital Color Doppler Ultrasound SystemSonoscape Company Limited20144—
+4K141855ClarityElekta, Ltd.20140—
+4K141806Clear Guide OneClear Guide Medical20142—
+4K140596NAVIOBlue Belt Technologies, Inc.201421—
+4K132744Acessa Guidance SystemHalt Medical, Inc.20141—
+4K140808Q-StationPhilips Ultrasound, Inc.201402
+4K140254EZONO 4000Ezono AG201413—
+4K133833Nuvis Diagnostic Ultrasound SystemPhilips Ultrasound, Inc.2014873
+4K131559Match Point System (TM), Surgicase Connect, Match Point System (TM) GuidesMaterialise NV201335—
+4K130126Signature Personalized Patient Care System - Glenoid Guide SystemBiomet, Inc.201338—
+4K121936NaviopfsBlue Belt Technologies, Inc.2012222
+4K120812RenaissanceMazor Robotics, Ltd.2012211
+4K112507Restoris Partial Knee Application (Pka), Rio Standard SystemMako Surgical Corporation2012466
+4K113228Renaissance SystemMazor Robotics, Ltd.201123—
+4K093425Mako Surgical Corp Robotic Arm Interactive Orthopedic System-ThaMako Surgical Corp.2010112
+4K091998Robotic Arm Interactive Orthopedic System-HipMako Surgical Corp.200912—
+4K083644Mako Surgical Tactile Guidance System-HipMako Surgical Corp.200913—
+4K053348Stryker Orthopaedics Rfid InstrumentationHowmedica Osteonics Corp.20060—
+4K041931Oec Olympus Mobile Fluoroscopy System with Integrated NavigationGe Oec Medical Systems, Inc.200415
+4K991943MRGP Optical Tracking UnitPhilips Medical Systems (Cleveland), Inc.19990—
+5K260123EPIQ Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC202601
+5K232320iSR`obot Mona Lisa 2.0Biobot Surgical Pte., Ltd.20230—
+5K230045HipCheckStryker Corp.20230—
+5K231862TruDi® Navigation System V3 (FG-2000-00)Acclarent, Inc.202301
+5K211529NAVIRFA ScopeNavifus Corporation20220—
+5K211098Breast Volume Navigator (BVN) Model G-2000Metritrack, Inc.20210—
+5K202373APEX 3D Total Ankle Replacement SystemParagon 28, Inc.20200—
+5K202609Instrument Clamps ElectromagneticStryker Corporation20200—
+5K202119AcuSee AS-P1000 SystemWeipeng (Suzhou) Medical Devices Co., Ltd.20200—
+5K202484Cordera Hip SystemConformis, Inc.202022
+5K192914Stimuplex Onvision SystemPhilips Medical Systems Nederland B.V.20200—
+5K201053PercuNav Image Fusion and Interventional NavigationPhilips Ultrasound, Inc.20201—
+5K193510Terason uSmart3200T Ultrasound SystemTeratech Corporation20201—
+5K190120Vinno 8, Vinno 6, Vinno 5Vinno Technology (Suzhou) Co.,Ltd20201—
+5K192198Conformis Hip SystemConformis, Inc.2019121
+5K190904Conformis BeneFIT Hip SystemConformis, Inc.201961
+5K190834Corin Optimized Position System Functional Hip Analysis (OPS FHA)Corin USA20195—
+5K190595Signature ONE SystemOrthosoft Inc (D/B/A Zimmer Cas)201910—
+5K190532TruDi NAV WireAcclarent, Inc.20190—
+5K182594E-CUBE i7Alpinion Medical Systems Co., Ltd.20191—
+5K182894HM70A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201910—
+5K181848ADAPT for Gamma3, Gamma3Stryker GmbH20181—
+5K181617E-CUBE 8Alpinion Medical Systems Co., Ltd.20180—
+5K181124Acessa ProVu SystemAcessa Health, Inc.20180—
+5K181277E-CUBE 12Alpinion Medical Systems Co., Ltd.20187—
+5K181061Corin Optimized Positioning System (OPS) FemoralCorin USA20181—
+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
+5K171687Relieva SpinPlus Nav Balloon Sinuplasty SystemAcclarent, Inc.20171—
+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—
+5K170584Mako Partial Knee ApplicationMako Surgical Corp.201722
+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
+5K161439E-CUBE 11Alpinion Medical Systems Co., Ltd.201612—
+5K161843Aplio i900/i800/i700 Diagnostic Ultrasound System, V2.0Toshibamedical Systems Corporation2016231
+5K161940Guidewire 0.6 Single UseFiagon GmbH20162—
+5K162329CX50 Diagnostic Ultrasound System, Sparq Diagnostic Ultrasound SystemPhilips Health Care2016273
+5K153602Materialise Glenoid Positioning SystemMaterialise NV201621
+5K153424E-CUBE i7Alpinion Medical Systems Co., Ltd.201614—
+5K152041Renaissance X SystemMazor Robotics, Ltd.201520—
+5K152983FUJIFILM SonoSite iViz Ultrasound SystemFUJIFILM Sonosite, Inc.20155—
+5K152899Philips Lumify Diagnostic Ultrasound SystemPhilips Healthcare, Inc.2015794
+5K142530Partial Knee Application (PKA)Mako Surgical Corporation20153—
+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
+5K143752Total Knee Application (TKA)Mako Surgical Corp.2015442
+5K150045S30/S40 Digital Color Doppler Ultraound SystemSonoscape Company Limited201517—
+5K143374BLUEPRINT Patient Specific InstrumentationTornier S.A.S.201531—