510(k) Report

Devices descending from K911783

552 later devices reach Allegro Viewing Wand through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K031337Acumen Surgical Navigation SystemBiomet, Inc.200381—
+4K991943MRGP Optical Tracking UnitPhilips Medical Systems (Cleveland), Inc.19990—
+4K983669Optical Tracking System with Surface Matching Module, Model OtsRadionics, Inc.19980—
+5K231862TruDi® Navigation System V3 (FG-2000-00)Acclarent, Inc.202301
+5K213411iSR’obot Mona Lisa 2.0Biobot Surgical Pte., Ltd.20211—
+5K202609Instrument Clamps ElectromagneticStryker Corporation20200—
+5K190532TruDi NAV WireAcclarent, Inc.20190—
+5K171709BR-FHUS Viewer 1.0Taihao Medical, Inc.20171—
+5K171309BR-FHUS Navigation 1.0Taihao Medical, Inc.20171—
+5K171687Relieva SpinPlus Nav Balloon Sinuplasty SystemAcclarent, Inc.20171—
+5K171105AIXPLORER® & AIXPLORER® Ultimate Ultrasound SystemsSupersonic Imagine201719—
+5K170716PercuNav Image Fusion and Interventional NavigationPhilips Ultrasound, Inc.20173—
+5K163120EPIQ 5 Diagnostic Ultrasound System; EPIQ 7 Diagnostic Ultrasound System; Affiniti 50…Philips Ultrasound, Inc.20175828
+5K161940Guidewire 0.6 Single UseFiagon GmbH20162—
+5K160807EPIQ 5 Diagnostic Ultrasound System, EPIQ 7Diagnostic Ultrasound System, Affiniti 50…Philips Ultrasound, Inc.201610033
+5K153004Clear Guide SCENERGYClear Guide Medical20164—
+5K153480ClearVue850 Diagnostic Ultrasound SystemPhilips Health Care2015210
+5K150773E-CUBE 15 Diagnostic Ultrasound SystemAlpinion Medical Systems Co., Ltd.201515—
+5K151451Aplio 500/400/300 Diagnostic Ultrasound System V6.0Toshibamedical Systems Corporation2015342
+5K150533Terason uSmart3200T Ultrasound SystemTeratech Corp.20152—
+5K150148Terason uSmart3300 Ultrasound SystemTeratech Corp.20150—
+5K142714S8 Exp/S9 Pro Portable Digital Color Doppler Ultrasound SystemSonoscape Company Limited20154—
+5K142815S22 Digital Color Doppler Ultrasound SystemSonoscape Company Limited20152—
+5K142710S9 Portable Digital Color Doppler Ultrasound SystemSonoscape Company Limited201519—
+5K142474S12 Digital Color Doppler Ultrasound SystemSonoscape Company Limited20144—
+5K140808Q-StationPhilips Ultrasound, Inc.201402
+5K140254EZONO 4000Ezono AG201413—
+5K133833Nuvis Diagnostic Ultrasound SystemPhilips Ultrasound, Inc.2014873
+5K111863Signature Planner,Signature GuidesMaterialise NV201271—
+5K081867Mako Surgical Tactile Guidance System Version 2.0Mako Surgical Corp.2008762
+5K073467Spineassist SystemMazor Surgical Technologies, Ltd.200832—
+5K072806Mako Surgical Tactile Guidance System (TGS)Mako Surgical Corp.2008781
+5K063607Spineassist SystemMazor Surgical Technologies, Ltd.200733—
+5K0619539900 Plus Mobile Fluoroscopy System with 3D and Navigation OptionsGe Oec Medical Systems200601
+5K051676Spineassist Device with Additional AccessoriesMazor Surgical Technologies, Ltd.200534—
+5K043223Depuy Cas Knee InstrumentationDePuy Orthopaedics, Inc.200511
+6K260123EPIQ Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC202601
+6K232320iSR`obot Mona Lisa 2.0Biobot Surgical Pte., Ltd.20230—
+6K211098Breast Volume Navigator (BVN) Model G-2000Metritrack, Inc.20210—
+6K201115Next Generation Balloon Dilation SystemAcclarent, Inc.20200—
+6K192914Stimuplex Onvision SystemPhilips Medical Systems Nederland B.V.20200—
+6K201053PercuNav Image Fusion and Interventional NavigationPhilips Ultrasound, Inc.20201—
+6K193510Terason uSmart3200T Ultrasound SystemTeratech Corporation20201—
+6K190120Vinno 8, Vinno 6, Vinno 5Vinno Technology (Suzhou) Co.,Ltd20201—
+6K182594E-CUBE i7Alpinion Medical Systems Co., Ltd.20191—
+6K182894HM70A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201910—
+6K181617E-CUBE 8Alpinion Medical Systems Co., Ltd.20180—
+6K181277E-CUBE 12Alpinion Medical Systems Co., Ltd.20187—
+6K180572AIXPLORER MACH Ultrasound Diagnostic Systems Aixplorer Mach 30, Aixplorer Mach 20…Supersonic Imagine201816—
+6K173021Aixplorer & Aixplorer Ultimate Ultrasound Diagnostic SystemsSupersonic Imagine201818—
+6K172732E-CUBE 8Alpinion Medical Systems Co., Ltd.201711—
+6K171677Clear Guide SCENERGYClear Guide Medical20173—
+6K171926C5 Diagnostic Ultrasound SystemGuangzhou Sonostar Technologies Co., Ltd.20171—
+6K172607Philips EPIQ 5 Diagnostic Ultrasound System, EPIQ 7 Diagnostic Ultrasound System…Philips Health Care20172831
+6K172055DUS-7000 Digital Color Doppler Ultrasound SystemAdvanced Instrumentations, Inc.20170—
+6K162719iTotal® Hip Replacement SystemConformis, Inc.2017174
+6K163702Aplio i900/i800/i700 Diagnostic Ultrasound System, V2.1Toshibamedical Systems Corporation2017221
+6K170078Medisono Color Doppler Ultrasound System, models P11 Portable, P11 EXPERT Portable, P12…Medisono, LLC20170—
+6K163690DC-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—
+6K170277DC-8/DC-8 PRO/DC-8 CV/DC-8 EXP/DC-8S Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.201720—
+6K1630826200 Ultrasound System and 6250 Ultrasound SystemEsaote, S.p.A.201792
+6K163020Xperius Ultrasound SystemPhilips Health Care201611
+6K161439E-CUBE 11Alpinion Medical Systems Co., Ltd.201612—
+6K161843Aplio i900/i800/i700 Diagnostic Ultrasound System, V2.0Toshibamedical Systems Corporation2016231
+6K162329CX50 Diagnostic Ultrasound System, Sparq Diagnostic Ultrasound SystemPhilips Health Care2016273
+6K152893Corin Optimized Positioning System (OPS)Corin USA20168—
+6K153424E-CUBE i7Alpinion Medical Systems Co., Ltd.201614—
+6K152983FUJIFILM SonoSite iViz Ultrasound SystemFUJIFILM Sonosite, Inc.20155—
+6K152899Philips Lumify Diagnostic Ultrasound SystemPhilips Healthcare, Inc.2015794
+6K150780Acetabular Cup Orientation SystemMaterialise NV20150—
+6K152396S12 Digital Color Doppler Ultrasound SystemSonoscape Medical Corp.20151—
+6K152164S8 Exp/S9 Pro Portable Digital Color Doppler Ultrasound SystemSonoscape Medical Corp.20153—
+6K152165S9 Portable Digital Color Doppler Ultrasound SystemSonoscape Medical Corp.201502
+6K150045S30/S40 Digital Color Doppler Ultraound SystemSonoscape Company Limited201517—
+6K140596NAVIOBlue Belt Technologies, Inc.201421—
+6K141369Visiq Diagnostic Ultra Sound SystemPhilips Ultrasound, Inc.20140—
+6K131559Match Point System (TM), Surgicase Connect, Match Point System (TM) GuidesMaterialise NV201335—
+6K130126Signature Personalized Patient Care System - Glenoid Guide SystemBiomet, Inc.201338—
+6K121936NaviopfsBlue Belt Technologies, Inc.2012222
+6K112507Restoris Partial Knee Application (Pka), Rio Standard SystemMako Surgical Corporation2012466
+6K102130Tenzing SystemMazor Surgical Technologies, Ltd.201031—
+6K093425Mako Surgical Corp Robotic Arm Interactive Orthopedic System-ThaMako Surgical Corp.2010112
+6K091998Robotic Arm Interactive Orthopedic System-HipMako Surgical Corp.200912—
+6K083644Mako Surgical Tactile Guidance System-HipMako Surgical Corp.200913—
+6K053348Stryker Orthopaedics Rfid InstrumentationHowmedica Osteonics Corp.20060—
+7K250030Flash Ultrasound System 5100 Point of CarePhilips Ultrasound, LLC202505
+7K223771Lumify Diagnostic Ultrasound SystemPhilips Ultrasound202322
+7K223804PercuNav Image Fusion and Interventional Navigation SystemPhilips Ultrasound, LLC20230—
+7K221911Vinno 6PRO, Vinno 6EXP, Vinno 5PRO, Vinno 5EXP, Vinno 3, Vinno 3PRO, Vinno 3EXPVinno Technology (Suzhou) Co.,Ltd20220—
+7K220169SonoMe Wireless Probe Type Ultrasound Scanner (Model: 5C, 5CB, H5C, 10L, 14L, 10LB…Bionet Co., Ltd.20220—
+7K213523X-CUBE i8, X-CUBE i9Alpinion Medical Systems Co., Ltd.20220—
+7K202373APEX 3D Total Ankle Replacement SystemParagon 28, Inc.20200—
+7K201188Clear Guide SCENERGYClear Guide Medical20201—
+7K202484Cordera Hip SystemConformis, Inc.202022
+7K201898Clear Guide SCENERGYClear Guide Medical20200—
+7K200655FibroScan® 630Echosens20200—
+7K200449X-Cube 90Alpinion Medical Systems Co., Ltd.20204—
+7K200450X-Cube 70Alpinion Medical Systems Co., Ltd.20204—
+7K201633Terason uSmart 3200T Plus Ultrasound SystemTeratech Corporation20200—
+7K201012EPIQ Diagnostic Ultrasound System Series, Affiniti Diagnostic Ultrasound System Series…Philips Ultrasound, Inc.2020185