510(k) Report

Devices descending from K934915

1,096 later devices reach Acuson Model 2001 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+12K203273FibroScan® Family of Products (Models: 502 Touch, 530 Compact, 430 Mini+, and 630)Echosens20219—
+12K201746Tempus Pro Patient MonitorRemote Diagnostic Technologies Limited202007
+12K201693DC-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—
+12K200449X-Cube 90Alpinion Medical Systems Co., Ltd.20204—
+12K200450X-Cube 70Alpinion Medical Systems Co., Ltd.20204—
+12K192879Acclarix AX8 Diagnostic Ultrasound System / Acclarix LX9 Series Diagnostic Ultrasound…Edan Instruments, Inc.20201—
+12K200699HS70A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20200—
+12K200304EPIQ Diagnostic Ultrasound SystemPhilips Ultrasound, Inc.2020243
+12K192170VistaScan USB Ultrasound Imaging SystemEmagine Solutions Technology, LLC20200—
+12K192903RS85 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.202021—
+12K192505HS50/HS60 Diagnostics Ultrasound SystemSamsung Medison Co., Ltd.201910—
+12K192319HERA W9 Diagnostic Ultrasound System, HERA W10 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201920—
+12K192791Diagnostic Ultrasound SystemEdan Instruments, Inc.20191—
+12K192573Dolphin Medical Imaging USB Ultrasound SystemDolphin Medical Imaging, LLC20190—
+12K192254InnoSight Diagnostic Ultrasound SystemQisda Corporation20190—
+12K192226Lumify Diagnostic Ultrasound SystemPhilips Health Care2019315
+12K191115RS85 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201923—
+12K190444HERA I10 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20190—
+12K190186Acclarix AX4 Diagnostic Ultrasound System / Acclarix LX4 Diagnostic Ultrasound SystemEdan Instruments, Inc.20190—
+12K182857EPIQ Diagnostic Ultrasound System, EPIQ 5 Diagnostic Ultrasound System, EPIQ 7…Philips Ultrasound, Inc.20181923
+12K182529Xperius Ultrasound SystemPhilips Ultrasound, Inc.20180—
+12K181098ACUSON SC2000 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.201819—
+12K173739Aloka Arietta 850Hitachi Healthcare Americas Corporation201872
+12K172056InnoSight Diagnostic Ultrasound SystemQisda Corporation20172—
+12K172342Voluson E6, Voluson E8, Voluson E10GE Healthcare201718—
+12K163510Poseidon Ultrasound SystemButterfly Network, Inc.201762
+12K172129HS40 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201735—
+12K170714VenueGE Medical Systems Ultrasound & Primary Care Diagnostics, LLC201735—
+12K170445Logiq S8GE Healthcare2017191
+12K163635ACUSON S1000/S2000/S3000 Diagnostic Ultrasound SystemsSiemens Medical Solutions USA, Inc. Ultrasound Group2017481
+12K163077LOGIQ E9, LOGIQ E9 XDClear 2.0GE Medical Systems Ultrasound and Primary Care Diagnostics201673—
+12K162269Voluson E6, Voluson E8, Voluson E10GE Healthcare201641—
+12K161706Vivid iqGe Medical Systems Ultrasound and Primary Care Diagnostics L201646—
+12K160357TrinityKoelis20161—
+12K160283S45 Digital Color Doppler Ultrasound SystemSonoscape Medical Corp.201615—
+12K160258X5 Digital Color Doppler Ultrasound SystemSonoscape Medical Corp.20162—
+12K160277LOGIQ F8 Expert, LOGIQ F8, LOGIQ F6GE Medical Systems Ultrasound and Primary Care Diagnostics201647—
+12K160524FibroScan 530 CompactEchosens201641—
+12K160182LOGIQ S7 ExpertGE Healthcare2016361
+12K152577Ultrasound System Sonimage HS 1Konica Minolta, Inc.201532
+12K151028LOGIQ eGE Medical Systems Ultrasound and Primary Care Diagnostics201560—
+12K150085GE EchoPACGe Vingmed Ultrasound AS20157—
+12K143452Logiq P9, Logiq P7GE Healthcare2015131—
+12K143027Xario 200, V3.0Toshibamedical Systems Corporation201451
+12K142517SoftVueDelphinus Medical Technologies, Inc.201449—
+12K141639Voluson S6, Voluson S8GE Healthcare2014151—
+12K1410936VT-D Ultrasound TransducerGe Vingmed Ultrasound AS201485—
+12K133533Logiq EGE Healthcare2014149—
+12K133034Logiq F SeriesGE Healthcare2014155—
+12K133277XARIO 100Toshibamedical Systems Corporation20142—
+12K133431VENUE 50GE Healthcare201360—
+12K131937Voluson I/EGE Healthcare201335—
+12K131267Voluson E6/E8/E8EXPERT/E8EXPERT Limited Edition/E10GE Healthcare2013270—
+12K1311184D VIEWGE Healthcare20131—
+12K122387Voluson P6, Voluson P8GE Healthcare2012201—
+12K121937E-Cube InnoAlpinion Medical Systems Co., Ltd.201215—
+13K263182EVO X30 Diagnostic Ultrasound System; EVO X20 Diagnostic Ultrasound System; EVO X10…Samsung Medison Co., Ltd.20260—
+13K261313Vivid Explorer/Vivid Advanced/Vivid FocusGE Medical Systems Ultrasound and Primary Care Diagnostics20260—
+13K253949SonoPort Series Digital Color Doppler Ultrasound System (SonoPort 1, SonoPort 1 Exp…CHISON Medical Technologies Co., Ltd.20260—
+13K251250ViewMate™ Multi Ultrasound System (VMM-ICE-01); ViewMate™ Multi Ultrasound System…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20250—
+13K251169Vivid PioneerGE Medical Systems Ultrasound and Primary Care Diagnostics20250—
+13K250020Diagnostic Ultrasound System (Recho R9W); Diagnostic Ultrasound System (Recho R9)…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20250—
+13K242519Lumify Diagnostic Ultrasound SystemPhilips Ultrasound20250Class I
+13K242670Lumify Diagnostic Ultrasound SystemPhilips Ultrasound20250Class I
+13K250228eHertz Functional Series Diagnostic Ultrasound System (eHertz C, eHertz E, eHertz R…Esonic Technology (Wuhan) Co., Ltd.20250—
+13K250214Acclarix AX8 Series Diagnostic Ultrasound System (Model: Acclarix AX7, Acclarix AX8…Edan Instruments, Inc.20250—
+13K242168Voluson Expert 18; Voluson Expert 20; Voluson Expert 22GE Medical Systems Ultrasound and Primary Care Diagnostics20241—
+13K242523ACUSON Sequoia Diagnostic Ultrasound System; ACUSON Sequoia Select Diagnostic Ultrasound…Siemens Medical Solutions USA, Inc.20242—
+13K242231Resona A10S, Resona A20 Pro, Resona A20T, Resona A20S, Resona A20W, Resona A20, Resona…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20241—
+13K240980EPIQ Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC20240—
+13K241201TEX20/TEX20 Pro/TEX20S/TEX20T/TEX20 Exp/TEX20 Elite/TEX10/TEX10 Pro/TEX10S/TEX10T/TEX10…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20240—
+13K241432MX7/MX7T/Vaus7/Zeus/ME7/Anesus ME7/Anesus ME7T/MX7P/MX7W/MX8/MX8T/Vaus8/ME8 Diagnostic…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20241—
+13K241979Pocket Ultrasound System (C10, C10TX, C10RL, C10RLpro)Beijing Konted Medical Technology Co.,Ltd20241—
+13K233841HD80 Series Ultrasound Diagnostic SystemQingdao Hisense Medical Equipment Co., Ltd.20240—
+13K232908Color Doppler Ultrasound Diagnostic System (CMS1700B), Color Doppler Ultrasound…Contec Medical Systems Co.,Ltd20240—
+13K240850EPIQ Series Diagnostic Ultrasound Systems; Affiniti Series Diagnostic Ultrasound SystemsPhilips Ultrasound, LLC202414—
+13K233439HD60 Series Ultrasound Diagnostic SystemQingdao Hisense Medical Equipment Co., Ltd.20240—
+13K232186LOGIQ eGe Medical Systems Ultrasound and Primary Care Diagnostic,20231—
+13K223830Ultrasound System 2300Bk Medical Aps202306
+13K223017Aplio i900/i800/i700 Diagnostic Ultrasound System, Software V7.0Canon Medical Systems Corporation20235—
+13K223902FibroScan® device (Models: 502 Touch, 530 Compact, 430 Mini+, 230, and 630)Echosens20231—
+13K221496Consona N6, Consona N6 Pro, Consona N6 Super, Consona AR, Consona N6S, Consona AE…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20220—
+13K221300Consona N9, Consona N9 Pro, Consona N9 Super, Consona Nova, Consona N9S, Consona NI…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20223—
+13K2226485000 Compact Series Ultrasound Systems (Ultrasound System 5500 G, Ultrasound System 5500…Philips Ultrasound, LLC202212
+13K220051TE Air Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.20223—
+13K213102ES1 SystemE-Scopics20223—
+13K211824HERA W9, HERA W10 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20213—
+13K211945V8 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.202113—
+13K211300X-CUBE 90Alpinion Medical Systems Co., Ltd.20213—
+13K211299X-CUBE 70Alpinion Medical Systems Co., Ltd.20213—
+13K212035FibroScan 230Echosens20215—
+13K211337DC-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—
+13K210959RS85 Diagnostic Ultrasound System, RS80 EVO Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20212—
+13K210068HS50 Diagnostic Ultrasound System, HS60 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20210—
+13K201965SonoEye P1/ SonoEye P1-G/ SonoEye V1/ SonoEye V1-G/ SonoEye G1/ SonoEye G1-G Digital…CHISON Medical Technologies Co., Ltd.20210—
+13K201967SonoEye P2/ SonoEye V2/ SonoEye G2 Digital Color Doppler Palm Ultrasound SystemCHISON Medical Technologies Co., Ltd.20210—
+13K201968SonoEye P3/ SonoEye V3/ Sono Eye G3 Digital Color Doppler Palm Ultrasound SystemCHISON Medical Technologies Co., Ltd.20210—
+13K201971SonoEye P5/ SonoEye V5/ SonoEye G5 Digital Color Doppler Palm Ultrasound SystemCHISON Medical Technologies Co., Ltd.20210—
+13K201969SonoEye P6/ SonoEye V6/ SonoEye G6 Digital Color Doppler Palm Ultrasound SystemCHISON Medical Technologies Co., Ltd.20210—
+13K203406Lumify Diagnostic Ultrasound SystemPhilips Ultrasound, Inc.202143