510(k) Report

Devices descending from K042770

932 later devices reach Modification to Acuson CV70 Cardiovascular System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+9K173090Aplio i900/i800/i700/i600 Diagnostic Ultrasound System, V2.4Toshibamedical Systems Corporation201821—
+9K172056InnoSight Diagnostic Ultrasound SystemQisda Corporation20172—
+9K172342Voluson E6, Voluson E8, Voluson E10GE Healthcare201718—
+9K172082S60 Series Digital Color Doppler Ultrasound SystemSonoscape Medical Corp.20175—
+9K172162ACUSON S3000 S2000 S1000 Diagnostic Ultrasound SystemsSiemens Healthcare201743—
+9K172129HS40 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201735—
+9K170999P50 Series Digital Color Doppler Ultrasound SystemSonoscape Medical Corp.20174—
+9K171766Acuson SC2000 Diagnostic Ultrasound SystemSiemens Medi Cal Solutions, Inc.201720—
+9K171000P60 Series Digital Color Doppler Ultrasound SystemSonoscape Medical Corp.20174—
+9K170714VenueGE Medical Systems Ultrasound & Primary Care Diagnostics, LLC201735—
+9K170878Vivid S60N, Vivid S70NGE Medical Systems Ultrasound & Primary Care Diagnostics, LLC2017102
+9K170847EchoPAC Software Only, EchoPAC Plug-inGE Medical Systems Ultrasound and Primary Care Diagnostics20174—
+9K170823Vivid E80, Vivid E90, Vivid E95GE Medical Systems Ultrasound and Primary Care Diagnostics2017353
+9K171314QLAB Advanced Quantification SoftwarePhilips Health Care201745—
+9K163702Aplio i900/i800/i700 Diagnostic Ultrasound System, V2.1Toshibamedical Systems Corporation2017221
+9K170303E5 Series Digital Color Doppler Ultrasound SystemSonoscape Medical Corp.20170—
+9K170069AmCAD-UVAmcad Biomed Corporation20170—
+9K163443Interson USB Ultrasound SystemInterson Corporation20173—
+9K170445Logiq S8GE Healthcare2017191
+9K163427X3 Exp/X3/X3 Pro/X1 Pro/X1 Digital Color Doppler Ultrasound SystemSonoscape Medical Corp.20170—
+9K163138Clarius Ultrasound SystemClarius Mobile Health Corp.201628—
+9K163077LOGIQ E9, LOGIQ E9 XDClear 2.0GE Medical Systems Ultrasound and Primary Care Diagnostics201673—
+9K162269Voluson E6, Voluson E8, Voluson E10GE Healthcare201641—
+9K162549Lumify Ultrasound SystemPhilips Health Care2016436
+9K161843Aplio i900/i800/i700 Diagnostic Ultrasound System, V2.0Toshibamedical Systems Corporation2016231
+9K161706Vivid iqGe Medical Systems Ultrasound and Primary Care Diagnostics L201646—
+9K161119SonoSite iViz Ultrasound SystemFUJIFILM Sonosite, Inc.20164—
+9K160357TrinityKoelis20161—
+9K160277LOGIQ F8 Expert, LOGIQ F8, LOGIQ F6GE Medical Systems Ultrasound and Primary Care Diagnostics201647—
+9K160420SpeqTSignostics Limited20161—
+9K160524FibroScan 530 CompactEchosens201641—
+9K160182LOGIQ S7 ExpertGE Healthcare2016361
+9K151028LOGIQ eGE Medical Systems Ultrasound and Primary Care Diagnostics201560—
+9K150085GE EchoPACGe Vingmed Ultrasound AS20157—
+9K143452Logiq P9, Logiq P7GE Healthcare2015131—
+9K141639Voluson S6, Voluson S8GE Healthcare2014151—
+9K140693Vscan with Dual ProbeGe Medical Sysyems Ultrasound & Primary Care Diagn201429—
+9K1410936VT-D Ultrasound TransducerGe Vingmed Ultrasound AS201485—
+9K133533Logiq EGE Healthcare2014149—
+9K133034Logiq F SeriesGE Healthcare2014155—
+9K133431VENUE 50GE Healthcare201360—
+9K131937Voluson I/EGE Healthcare201335—
+9K131822Ultraextend Usws-900A V2.1 and V3.1Toshiba America Medical Systems, In.C20130—
+9K131267Voluson E6/E8/E8EXPERT/E8EXPERT Limited Edition/E10GE Healthcare2013270—
+9K1311184D VIEWGE Healthcare20131—
+9K123992Aplio 500/400/300 V3.0Toshibamedical Systems Corporation201382—
+9K122387Voluson P6, Voluson P8GE Healthcare2012201—
+9K121937E-Cube InnoAlpinion Medical Systems Co., Ltd.201215—
+10K251417ReVISION 2Argus Cognitive, Inc.20260—
+10K260192DIANAROPCA ApS20260—
+10K253949SonoPort Series Digital Color Doppler Ultrasound System (SonoPort 1, SonoPort 1 Exp…CHISON Medical Technologies Co., Ltd.20260—
+10K260234MSK GoSmart Alfa Teknoloji San. Ve Tic. A.S.20260—
+10K252558Lumify Diagnostic Ultrasound SystemPhilips Ultrasound, LLC20260—
+10K2532886450 Ultrasound System (MyLabE80); 6450 Ultrasound System (MyLabE85)Esaote, S.p.A.20260—
+10K253593Clarius Ejection Fraction AIClarius Mobile Health Corp.20260—
+10K252557Lumify Diagnostic Ultrasound SystemPhilips Ultrasound, LLC20250—
+10K252235PVAD IQ SoftwareUltrasight, Ltd.20250—
+10K2533107600 Ultrasound System (MyLabC25); 7600 Ultrasound System (MyLabC30)Esaote, S.p.A.20250—
+10K253487ACUSON Maple Diagnostic Ultrasound System; ACUSON Maple Select Diagnostic Ultrasound…Siemens Medical Solutions USA, 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—
+10K250020Diagnostic Ultrasound System (Recho R9W); Diagnostic Ultrasound System (Recho R9)…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20250—
+10K250110Diagnostic Ultrasound System (MX6); Diagnostic Ultrasound System (MX6S); Diagnostic…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20250—
+10K250226Clarius Median Nerve AIClarius Mobile Health Corp.20250—
+10K250087Vscan AirGE Medical Systems Ultrasound and Primary Care Diagnostics20250—
+10K250214Acclarix AX8 Series Diagnostic Ultrasound System (Model: Acclarix AX7, Acclarix AX8…Edan Instruments, Inc.20250—
+10K241949Digital Color Doppler Ultrasound System (P60 Series)Sonoscape Medical Corp.20250—
+10K242359Strain AI (SAI001)Exo, Inc.20240—
+10K242231Resona A10S, Resona A20 Pro, Resona A20T, Resona A20S, Resona A20W, Resona A20, Resona…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20241—
+10K241201TEX20/TEX20 Pro/TEX20S/TEX20T/TEX20 Exp/TEX20 Elite/TEX10/TEX10 Pro/TEX10S/TEX10T/TEX10…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20240—
+10K232331InVision Precision LVEF (LVEF)InVision Medical Technology Corporation20240—
+10K231659MS55 Plus Digital Color Doppler Ultrasound System (MS55); P25 Expert Digital Color…Medisono20240—
+10K233734Interson USB Ultrasound SystemInterson Corporation20230—
+10K231354Pocket Ultrasound System (C10)Beijing Konted Medical Technology Co.,Ltd20232—
+10K232501AI Platform (AIP001)Exo, Inc.20231—
+10K232186LOGIQ eGe Medical Systems Ultrasound and Primary Care Diagnostic,20231—
+10K232145ACUSON Sequoia Diagnostic Ultrasound System, ACUSON Sequoia Select Diagnostic Ultrasound…Siemens Medical Solutions USA, Inc.20234—
+10K232500Lumify Diagnostic Ultrasound SystemPhilips Ultrasound202301
+10K231685TE Air Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.20232—
+10K231764Ultrasound System 1300Bk Medical Aps202301
+10K223422Emory Cardiac Toolbox 4.3Syntermed20230—
+10K223902FibroScan® device (Models: 502 Touch, 530 Compact, 430 Mini+, 230, and 630)Echosens20231—
+10K222970LVivo IQSDia Imaging Analysis, Ltd.20236—
+10K221911Vinno 6PRO, Vinno 6EXP, Vinno 5PRO, Vinno 5EXP, Vinno 3, Vinno 3PRO, Vinno 3EXPVinno Technology (Suzhou) Co.,Ltd20220—
+10K222441Ultrasound System 2300Bk Medical Aps20221—
+10K222191Aixplorer MACH30 / SUPERSONIC MACH30, Aixplorer MACH20 / SUPERSONIC , MACH20, SUPERSONIC…Supersonic Imagine20221—
+10K2226485000 Compact Series Ultrasound Systems (Ultrasound System 5500 G, Ultrasound System 5500…Philips Ultrasound, LLC202212
+10K221089P12 Elite Series Digital Color Doppler Ultrasound SystemSonoscape Medical Corp.20220—
+10K221140P20 Elite Series Digital Color Doppler Ultrasound SystemSonoscape Medical Corp.20220—
+10K221147Vivid T8, Vivid T9GE Medical Systems Ultrasound and Primary Care Diagnostics20221—
+10K212376Caas QardiaPie Medical Imaging BV20220—
+10K212333Aplio i900/i800/i700 Diagnostic Ultrasound System, Software V6.5Canon Medical Systems Corporation202261
+10K213102ES1 SystemE-Scopics20223—
+10K213544Tomtec-ArenaTomtec Imaging Systems GmbH20226—
+10K213275EchoGo Core (2.0)Ultromics Limited20211—
+10K212466LVivo SeamlessDia Imaging Analysis, Ltd.20211—
+10K211824HERA W9, HERA W10 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20213—
+10K211945V8 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.202113—
+10K211597EPIQ Series Diagnostic Ultrasound System, Affiniti Series Diagnostic Ultrasound SystemPhilips Medical Systems202117—
+10K211300X-CUBE 90Alpinion Medical Systems Co., Ltd.20213—