510(k) Report

Devices descending from K990214

450 later devices reach Fluoronav Module for the Stealthstation System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+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
+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
+5K162329CX50 Diagnostic Ultrasound System, Sparq Diagnostic Ultrasound SystemPhilips Health Care2016273
+5K153602Materialise Glenoid Positioning SystemMaterialise NV201621
+5K153424E-CUBE i7Alpinion Medical Systems Co., Ltd.201614—
+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—
+5K143668NavioBlue Belt Technologies, Inc.201520—
+5K141369Visiq Diagnostic Ultra Sound SystemPhilips Ultrasound, Inc.20140—
+5K121765Sculptor Robotic Guidance Arm (Rga)Stanmore Implants Worldwide, Ltd.20130—
+5K121064Makoplasty Total Hip Application, Rio Standard SystemMako Surgical Corporation2012912
+6K252067Velora Acetabular SystemRestor3D, Inc.20250—
+6K250030Flash Ultrasound System 5100 Point of CarePhilips Ultrasound, LLC202505
+6K242121mBôs (Monogram mBôs TKA System)Monogram Orthopaedics, Inc.20250—
+6K231178ACTERA™ hip systemConformis, Inc.20230—
+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—
+6K221104Actera™ hip systemConformis, Inc.202211
+6K220468BENCOX Mirabo Cup SystemCorentec Co., Ltd.20221—
+6K221059Identity Imprint Knee Replacement System (including Identity Imprint Posterior…Conformis, Inc.20227—
+6K213523X-CUBE i8, X-CUBE i9Alpinion Medical Systems Co., Ltd.20220—
+6K213389Identity Imprint Cruciate Retaining (CR) Knee Replacement System and Identity Imprint…Conformis, Inc.20218—
+6K212560Signature™ ONE SystemOrthosoft Inc (D/B/A Zimmer Cas)20217—
+6K210121ROSA Partial Knee SystemOrthosoft D/B/A Zimmer Cas20211—
+6K201188Clear Guide SCENERGYClear Guide Medical20201—
+6K193545Corin Optimized Positioning System (OPS) FemoralCorin USA20200—
+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—
+6K193042Optimized Positioning System (OPS) ReViewCorin USA20200—
+6K200615Signature ONE SystemOrthosoft Inc (D/B/A Zimmer Cas)20208—
+6K201012EPIQ Diagnostic Ultrasound System Series, Affiniti Diagnostic Ultrasound System Series…Philips Ultrasound, Inc.2020185
+6K192656Optimized Positioning System (OPS) InsightCorin USA20203—
+6K190738MyShoulder Placement GuidesMedacta International S.A.20194—
+6K191007Aixplorer MACH 30, Aixplorer MACH 20 Ultrasound Diagnostic SystemsSupersonic Imagine20195—
+6K192254InnoSight Diagnostic Ultrasound SystemQisda Corporation20190—
+6K192074Signature ONE SystemOrthosoft Inc (D/B/A Zimmer Cas)20199—
+6K191467Aplio i900/i800/i700/i600 Diagnostic Ultrasound System, V4.0Canon Medical Systems Corporation20199—
+6K191055HS40 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20199—
+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
+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—
+6K172054Materialise Glenoid Positioning SystemMaterialise NV20170—
+6K171891ZS3 Ultrasound System, z.one pro Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.20174—
+6K171034M9 Diagnostic Ultrasound System, M9T Diagnostic Ultrasound System, M9CV Diagnostic…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.201712—
+6K170893Materialise Glenoid Positioning SystemMaterialise NV201711
+6K170891Mako Partial Knee ApplicationMako Surgical Corp.201723
+6K170581Mako Total Knee ApplicationMako Surgical Corp.2017381
+6K163443Interson USB Ultrasound SystemInterson Corporation20173—
+6K161789BLUEPRINT Patient Specific InstrumentationTornier S.A.S.20160—
+6K163138Clarius Ultrasound SystemClarius Mobile Health Corp.201628—
+6K162549Lumify Ultrasound SystemPhilips Health Care2016436
+6K160555BLUEPRINT Patient Specific InstrumentationTornier S.A.S.201625—
+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—
+6K152574NavioBlue Belt Technologies, Inc.201519—
+6K141989Makoplasty Total Hip Allpication, Rio Standard SystemMako Surgical Corporation201483
+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—
+7K252557Lumify Diagnostic Ultrasound SystemPhilips Ultrasound, LLC20250—
+7K243509Archer PSI System3D-Side20250—
+7K233992Precision AI Surgical Planning System (PAI-SPS)Precision AI Pty, Ltd.20242—
+7K234030Clear Guide SCENERGYClear Guide Medical20240—
+7K233734Interson USB Ultrasound SystemInterson Corporation20230—
+7K231354Pocket Ultrasound System (C10)Beijing Konted Medical Technology Co.,Ltd20232—
+7K232425Signature™ ONE SystemOrthosoft Inc. (D/B/A) Zimmer Cas)20232—
+7K2301796440 MyLabX90Esaote, S.p.A.202341
+7K232533ROSA Partial Knee SystemOrthosoft D/B/A Zimmer Cas20230—
+7K232500Lumify Diagnostic Ultrasound SystemPhilips Ultrasound202301
+7K230066Carnation series Diagnostic Ultrasound SystemShenzhen Wisonic Medical Technology Co., Ltd.20230—
+7K222007Arthrex Virtual Implant Positioning (VIP) SystemArthrex, Inc.20233—