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
+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—
+9K250228eHertz Functional Series Diagnostic Ultrasound System (eHertz C, eHertz E, eHertz R…Esonic Technology (Wuhan) Co., Ltd.20250—
+9K243768iTotal® Identity™ Cruciate Retaining 3DP Porous Knee Replacement SystemRestor3D, Inc.20250—
+9K241292MyShoulder Planner (5.3SSWPL)Medacta International S.A.20250—
+9K241949Digital Color Doppler Ultrasound System (P60 Series)Sonoscape Medical Corp.20250—
+9K242800The 5000 Compact Series Ultrasound SystemsPhilips Ultrasound, LLC20240—
+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—
+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—
+9K232265BLUEPRINT™ Patient Specific InstrumentationTornier S.A.S.20243—
+9K233439HD60 Series Ultrasound Diagnostic SystemQingdao Hisense Medical Equipment Co., Ltd.20240—
+9K231659MS55 Plus Digital Color Doppler Ultrasound System (MS55); P25 Expert Digital Color…Medisono20240—
+9K232426Identity Imprint Porous Cruciate Retaining (CR) Knee Replacement System (KRS) with…Conformis, Inc.20230—
+9K230202TMINI™ Miniature Robotic SystemTHINK Surgical, Inc.2023101
+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—
+9K222405Smart SPACE Shoulder Planner and 3D PositionersLima Corporate S.P.A.20220—
+9K221928ROSA® Knee SystemOrthosoft D/B/A Zimmer Cas20228—
+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—
+9K220733OptiVu ROSA MxROrthosoft Inc (D/B/A Zimmer Cas)20221—
+9K213873SkyWalker Total Knee SystemMicroport Navibot International, LLC20220—
+9K220269HM70 EVO Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20223—
+9K213708ROSA® Knee SystemOrthosoft Inc (D/B/A Zimmer Cas)20220—
+9K213546ExactechGPS Total Shoulder Application, Equinoxe Planning SoftwareBlue Ortho202281
+9K211359Tornier Perform™ Patient-Matched Primary Reversed Glenoid and BLUEPRINT™ Patient…Tornier, Inc.202182
+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—
+9K210998ROSA Hip SystemOrthosoft D/B/A Zimmer Cas20211—
+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—
+9K202151Smart SPACE Shoulder SystemTechmah Medical, LLC20211—
+9K202454Smart SPACE Shoulder SystemTechmah Medical, LLC20201—
+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—
+9K193515Mako Total Knee ApplicationMako Surgical Corp.202016
+9K193128Mako Total Hip ApplicationMako Surgical Corp.20203—
+9K192107Clarius Ultrasound ScannerClarius Mobile Health Corp.201910—
+9K180271NAVIO™ Surgical System (NAVIO system)Blue Belt Technologies, Inc.201816—
+9K172993P20 Series Digital Color Doppler Ultrasound SystemSonoscape Medical Corp.20171—
+9K173058P10 Series Digital Color Doppler Ultrasound SystemSonoscape Medical Corp.20171—
+10K252788Tornier Perform™ Reversed Monopost Glenoid (Perform Mono)Tornier, Inc.20260—
+10K252841Real Intelligence™ Cori™ XT (Cori XT)Blue Belt Technologies, Inc.20250—
+10K251853Consona N5, Consona N5 Pro, Consona N5 Super, Consona N5 Exp, Consona ER, Consona N5S…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20251—
+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—
+10K250886EPIQ Series Diagnostic Ultrasound Systems; Affiniti Series Diagnostic Ultrasound SystemsPhilips Ultrasound, LLC20250—
+10K243793EPIQ Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC20250—
+10K250110Diagnostic Ultrasound System (MX6); Diagnostic Ultrasound System (MX6S); Diagnostic…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20250—
+10K251110EPIQ Series Diagnostic Ultrasound Systems; Affiniti Series Diagnostic Ultrasound SystemsPhilips Ultrasound, LLC20250—
+10K243751Mako Total Hip Application 5.0Mako Surgical Corp.20251—
+10K243794EPIQ Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC20255—
+10K242020EPIQ Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC20243—
+10K241491Blueprint Patient-Specific Instrumentation; Shoulder iD Primary Reversed GlenoidStryker Corporation (Tornier, S.A.S.)20241—
+10K241582Aplio i900/i800/i700 Diagnostic Ultrasound System, Software V7.0 (TUS-AI900, TUS-AI800…Canon Medical Systems Corporation20240—
+10K240721ExcelsiusFlex™Globus Medical, Inc.20240—
+10K233199ROSA® Shoulder SystemOrthosoft Inc (D/B/A Zimmer Cas)20243—
+10K233195Aplio i900, Aplio i800 and Aplio i700 Software V8.1 Diagnostic Ultrasound SystemCanon Medical Systems Corporation20243—
+10K232808Butterfly iQ3 Ultrasound SystemButterfly Network, Inc.20241—
+10K233112HM70 EVO Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20232—
+10K232521ExactechGPS® Total Ankle ApplicationBlue Ortho20230—
+10K232802TMINI™ Miniature Robotic SystemTHINK Surgical, Inc.20239—
+10K230567OptiVu™ ROSA® MxROrthosoft Inc (D/B/A Zimmer Cas)20230—
+10K231162ROSA Hip SystemOrthosoft Inc (D/B/A Zimmer Cas)20230—
+10K231190EPIQ Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC202314
+10K230243ROSA® Knee SystemOrthosoft D/B/A Zimmer Cas20236—
+10K230180Rosa Knee SystemOrthosoft Inc (D/B/A Zimmer Cas)20230—
+10K222596S90 Exp Series Digital Color Doppler Ultrasound SystemSonoscape Medical Corp.20233—
+10K220774RobPath® Total Hip ApplicationHangzhou Lancet Robotics Co., Ltd.20220—
+10K222198Exo Iris (El2001)Exo Imaging, Inc.20220—
+10K222365Leltek Ultrasound Imaging System (Model: LU700 Series)Leltek, Inc.20227—
+10K211665SONON Ultrasound Imaging System, Model: SONON300CHealcerion Co., Ltd.20220—
+10K220490ImaCor Zura Handheld ZHH-010Imacor, Inc.202202
+10K212960Aplio a550, Aplio a450, and Aplio a, Diagnostic Ultrasound System, Software V6.5Canon Medical Systems Corporation202201
+10K211746Pocket Ultrasound SystemGuangdong Youkey Medical Co., Ltd.20221—
+10K213436Clarius Ultrasound ScannerClarius Mobile Health Corp.20212—
+10K211232Apache Ultrasound SystemAco Healthcare Co., Ltd.20210—
+10K202074Apache Ultrasound System (Model C62)Compal Electronics, Inc.20200—
+10K191223NAVIOBlue Belt Technologies, Inc.201915—
+10K182648X5 Series Digital Color Doppler Ultrasound SystemSonoscape Medical Corp.20190—
+11K254027Digital Color Doppler Ultrasound System (Marvo 95/Marvo 95 Elite/Marvo 90/Marvo 90…Sonoscape Medical Corp.20260—
+11K260667Alturion Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC20261—
+11K260680EPIQ Series Diagnostic Ultrasound Systems; Affiniti Series Diagnostic Ultrasound SystemsPhilips Ultrasound, LLC202601
+11K260582ROSA® Shoulder SystemOrthosoft Inc. (d/b/a) Zimmer CAS20260—
+11K254028Digital Color Doppler Ultrasound System (Autra RS, Autra 90, Autra Senior, Autra CV…Sonoscape Medical Corp.20260—
+11K260846Diagnostic Ultrasound System (MU9);Diagnostic Ultrasound System (MU9S);Diagnostic…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20260—
+11K253674Blueprint Patient-Specific InstrumentationStryker Corporation (Tornier, S.A.S.)20260—
+11K252148Butterfly Gestational Age ToolButterfly Network, Inc.20260—
+11K254099EVO Q30 Diagnostic Ultrasound System; EVO Q20 Diagnostic Ultrasound System; EVO Q10…Samsung Medison Co., Ltd.20261—