510(k) Report

Devices descending from K032111

955 later devices reach Acuson CV70 Cardiovascular System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K110673HI Vision Ascendus Diagnostic Ultrasound ScannerHitachi Medical Systems America, Inc.201185—
+6K112451S8 Diagnostic Ultrasound SystemSonoscape Company Limited20110—
+6K111302Mylabseven, MylabalphaEsaote, S.p.A.201124—
+6K110414Qlab 8.1 Quantification SoftwarePhilips Ultrasound, Inc.20110—
+6K110688MylabgoldEsaote2011251
+6K1107464D LV-Analysis 3.0Tomtec Imaging Systems GmbH201180—
+6K110510S20 Digital Color Doppler Ultrasound SystemSonoscape Company Limited20112—
+6K110999Digital Ultrasonic Diagnostic Imaging SystemEdan Instruments, Inc.201122—
+6K110199DC-T6 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.2011117—
+6K1037824D MV-Assessment 2.0Tomtec Imaging Systems GmbH201179—
+6K1031526250 Ultrasound SytemsEsaote, S.p.A.201135—
+6K102997Sonixtablet Ultrasound ScannerUltrasonix Medical Corporation201077—
+6K102865DC-7 Diagnostic Ultrasound System, DC-3/DC-3T Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.20100—
+6K102901HI Vision Avius Diagnostic Ultrasound ScannerHitachi Medical Systems America, Inc.2010601
+6K101337A6 Portable Ultrasonic Diagnostic SystemSonoscape Company Limited20101—
+6K101091Z.One Ultra Ultrasound SystemZonare Medical Systems, Inc.2010132—
+6K100989Zura Tee System with Claritee ProbeImacor, Inc.201011
+6K092271GE Logiq E9 BT2010 Diagnostic Ultrasound System, Model 5205000-3, 5205000-4GE Healthcare20095691
+6K083421MR-Touch OptionGe Medical Systems, LLC20094—
+7K260748ES-SeriesE-Scopics20260—
+7K250955XC11 ICE System, USAYorlabs, Inc.20250—
+7K250026Shear Wave Quantificational Ultrasound Diagnostic System…Wuxi Hisky Medical Technologies Co., Ltd.20250—
+7K243880Shear Wave Quantificational Ultrasound Diagnostic System (Mini900, Mini990, Mini800…Wuxi Hisky Medical Technologies Co., Ltd.20250—
+7K232661Myocardial Strain Software ApplicationCircle Cardiovascular Imaging20231—
+7K223570SonoAir Series Digital Color Doppler Ultrasound SystemCHISON Medical Technologies Co., Ltd.20230—
+7K221340iNod Ultrasound Guided Biopsy Needle (UPN: M00502060), iNod Ultrasound Guidance Console…Boston Scientific Corporation20230—
+7K220956Libby Echo:PrioDyad Medical, Inc.20221—
+7K213487ACUSON P500 Ultrasound SystemSiemens Medical Solutions USA, Inc.20221—
+7K210318Apogee 6500,Apogee 6300,Apogee 6200 Digital Color Doppler Ultrasound Imaging SystemShantou Institute of Ultrasonic Instruments Co., Ltd. (Siui)20210—
+7K210791Us2.v1Eko.Ai Pte Ltd. D/B/A Us2.Ai20213—
+7K211859ACUSON Sequoia Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.202171
+7K202035Vscan AirGE Medical Systems Ultrasound and Primary Care Diagnostics20203—
+7K203128Evis Eus Endoscopic Ultrasound Center Olympus EU-ME2/Evis Eus Endoscopic Ultrasound…Olympus Medical Systems Corp.20201—
+7K202683ACUSON Sequoia Diagnostic Ultrasound System, ACUSON SC2000 Diagnostic Ultrasound System…Siemens Medical Solutions USA, Inc.20206—
+7K200621Caption Interpretation Automated Ejection Fraction SoftwareCaption Health202031
+7K201389Resoundant Acoustic Driver SystemResoundant, Inc.20201—
+7K200232LVivo Software ApplicationDia Imaging Analysis, Ltd.202019—
+7K201130ACUSON Juniper Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.2020144
+7K201062syngo Ultrasound Apps Suite (sUSAS)Siemens Medical Solutions USA, Inc.20200—
+7K193518KosmosEchoNous, Inc.20201—
+7K192372ASCEND Image ViewerAscend Hit20200—
+7K191347Paragon XHD Diagnostic Ultrasound SystemShenzhen Wisonic Medical Technology Co., Ltd.20200—
+7K191922ACUSON P200 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.201923—
+7K183041Full Digital Colour Doppler Ultrasonic Diagnostic SystemWuhan Zoncare Bio-medical Electronics Co., Ltd.20190—
+7K1910727410 Ultrasound System (MyLabSigma)Esaote, S.p.A.20190—
+7K1909896400 Ultrasound System (MyLabX6, MyLabX7)Esaote, S.p.A.20190—
+7K1904477400 Ultrasound SystemsNavigant Consulting - on Behalf of Esaote S.P.A.20190—
+7K181637DC-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—
+7K181934Vivid T8, Vivid T9GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC20183—
+7K181617E-CUBE 8Alpinion Medical Systems Co., Ltd.20180—
+7K180974CBit Series Digital Color Doppler Ultrasound SystemCHISON Medical Technologies Co., Ltd.20183—
+7K180912TE7/TE5 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.201811—
+7K180572AIXPLORER MACH Ultrasound Diagnostic Systems Aixplorer Mach 30, Aixplorer Mach 20…Supersonic Imagine201816—
+7K180461Navi e/Navi s/Navi X Diagnostic Ultrasound SystemShenzhen Wisonic Medical Technology Co., Ltd.20181—
+7K173962Viamo c100 TUS-VC100 Diagnostic Ultrasound SystemToshibamedical Systems Corporation20180—
+7K180408U60 Diagnostic Ultrasound SystemEdan Instruments, Inc.20180—
+7K173513WS80A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.2018321
+7K173204RS85 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201839—
+7K1732916440 Ultrasound SystemEsaote, S.p.A.20188—
+7K171207FUJIFILM Ultrasonic Processor SP-900 and FUJIFILM Ultrasonic Probe PB2020-MFujifilm Medical Systems U.S.A, Inc.20181—
+7K173471DC-80/DC-80 PRO/DC-80 EXP/DC-80S/DC-85 DiagnosticShenzhen Mindray Bio-Medical Electronics Co., Ltd.20181—
+7K172732E-CUBE 8Alpinion Medical Systems Co., Ltd.201711—
+7K173000Apogee 2100 Digital Color Doppler Ultrasound Imaging System Apogee 2300 Digital Color…Shantou Institute of Ultrasonic Instruments Co., Ltd. (Siui)20173—
+7K173265UltraVision 2 Diagnostic Ultrasound SystemWinprobe Corporation20172—
+7K172607Philips EPIQ 5 Diagnostic Ultrasound System, EPIQ 7 Diagnostic Ultrasound System…Philips Health Care20172831
+7K171891ZS3 Ultrasound System, z.one pro Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.20174—
+7K171233Resona 7/Resona 7CV/Resona 7EXP/Resona 7S/Resona 7OB Diagnostic Ultrasound SystemShenzhen Mindray Bio-Meidcal Electronics Co., Ltd.201721—
+7K171048RS80A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201750—
+7K172162ACUSON S3000 S2000 S1000 Diagnostic Ultrasound SystemsSiemens Healthcare201743—
+7K172374ACUSON NX2 Diagnostic Ultrasound System, ACUSON NX2 Elite Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.201712
+7K171824Acclarix AX8 Diagnostic Ultrasound System, Acclarix LX8 Diagnostic Ultrasound SystemEdan Instruments, Inc.20177—
+7K171105AIXPLORER® & AIXPLORER® Ultimate Ultrasound SystemsSupersonic Imagine201719—
+7K171034M9 Diagnostic Ultrasound System, M9T Diagnostic Ultrasound System, M9CV Diagnostic…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.201712—
+7K171314QLAB Advanced Quantification SoftwarePhilips Health Care201745—
+7K170078Medisono Color Doppler Ultrasound System, models P11 Portable, P11 EXPERT Portable, P12…Medisono, LLC20170—
+7K163119NaviSuite SSI EditionMedcom GmbH20171—
+7K170069AmCAD-UVAmcad Biomed Corporation20170—
+7K162902ARIETTA Prologue Diagnostic Ultrasound system and TransducersHitachi, Ltd.20160—
+7K162065Ultrasound System SONIMAGE HS1Konica Minolta, Inc.201622
+7K160559NOBLUS™ Ultrasound Diagnostic SystemHitachi Medical Corporation201601
+7K153539RS80A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201659—
+7K162221ACUSON SC2000 Diagnostic Ultrasound SystemSiemens Medical Solutions Inc. Ultrasound Group2016481
+7K162094RS80A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201664—
+7K152126Ust-5550-R; Ust-5536-R; L43KHitachi Aloka Medical America, Inc.201601
+7K1619555D ViewerSamsung Medison Co., Ltd.20163—
+7K160807EPIQ 5 Diagnostic Ultrasound System, EPIQ 7Diagnostic Ultrasound System, Affiniti 50…Philips Ultrasound, Inc.201610033
+7K160790Acclarix LX8 Diagnostic Ultrasound SystemEdan Instruments, Inc.20169—
+7K160381TE7 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.201613—
+7K153424E-CUBE i7Alpinion Medical Systems Co., Ltd.201614—
+7K153529WS80A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.2016891
+7K153408HM70A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201565—
+7K153480ClearVue850 Diagnostic Ultrasound SystemPhilips Health Care2015210
+7K152962HS70A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201590—
+7K152369ACUSON S1000, S2000, S3000 Diagnostic Ultrasuond SystemSiemens Medical Solutions USA, Inc. Ultrasound Group201554—
+7K150239FibroScanEchosens201525—
+7K1518083D/5D ViewerSamsung Medison Co., Ltd.20154—
+7K150773E-CUBE 15 Diagnostic Ultrasound SystemAlpinion Medical Systems Co., Ltd.201515—
+7K150533Terason uSmart3200T Ultrasound SystemTeratech Corp.20152—
+7K150045S30/S40 Digital Color Doppler Ultraound SystemSonoscape Company Limited201517—
+7K150478A35 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201597—