510(k) Report

Devices descending from K121138

198 later devices reach Acuson S3000 Diagnostic Ultrasound System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K132804Acuson S1000 / S2000 / S3000Siemens Medical Solutions USA, Inc. Ultrasound Gro2013733
+1K130881Acuson S2000 and S3000Siemens Medical Solutions USA, Inc.2013116—
+1K130739Acuson S2000 and S3000 Diagnostic Ultrasound SystemsSiemens Medical Solutions USA, Inc.2013177—
+2K1630826200 Ultrasound System and 6250 Ultrasound SystemEsaote, S.p.A.201792
+2K153421HI Vision Ascendus, HV Ascendus, AscendusHitachi Aloka Medical America, Inc.20160—
+2K151663RS80A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201596—
+2K150002iNSIGHT Color Doppler Ultrasound SystemSaset (Chengdu), Inc.20150—
+2K142368Noblus Diagnostic Ultrasound ScannerHitachi Aloka Medical, Ltd.2015581
+2K143089WS80A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201499—
+2K141846Acuson X700 Ultrasound System, Acuson X600 Ultrasound SystemSiemens Medical Solutions USA, Inc.201441—
+2K140959Acuson S1000, S2000, S3000 Diagnostic Ultrasound SystemsSiemens Medical Solutions USA, Inc.201460—
+2K133329Ugeo WS80A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.2013102—
+3K173513WS80A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.2018321
+3K180039ACUSON P600 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.201825—
+3K1732916440 Ultrasound SystemEsaote, S.p.A.20188—
+3K171048RS80A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201750—
+3K163396ACUSON P500 Ultrasound SystemSiemens Medical Solutions USA, Inc.201727—
+3K162902ARIETTA Prologue Diagnostic Ultrasound system and TransducersHitachi, Ltd.20160—
+3K162065Ultrasound System SONIMAGE HS1Konica Minolta, Inc.201622
+3K160559NOBLUS™ Ultrasound Diagnostic SystemHitachi Medical Corporation201601
+3K153539RS80A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201659—
+3K162094RS80A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201664—
+3K152126Ust-5550-R; Ust-5536-R; L43KHitachi Aloka Medical America, Inc.201601
+3K1619555D ViewerSamsung Medison Co., Ltd.20163—
+3K161787ACUSON NX2 Diagnostic Ultrasound SystemsSiemens Medical Solutions USA, Inc.2016301
+3K160853Apogee 5500/Apogee 5300/ Apogee 5800 Digital Color Doppler Ultrasound Imaging SystemShantou Institute of Ultrasonic Instruments Co., Ltd. (Siui)20165—
+3K153424E-CUBE i7Alpinion Medical Systems Co., Ltd.201614—
+3K153529WS80A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.2016891
+3K153408HM70A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201565—
+3K152962HS70A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201590—
+3K152469ACUSON NX3 Elite / NX3 Diagnostic Ultrasound SystemSiemens Medical Solutions, Inc., Ultrasound Division2015332
+3K1518083D/5D ViewerSamsung Medison Co., Ltd.20154—
+3K150478A35 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201597—
+3K150050ACUSON P500 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.201528—
+3K143264H60 V2.00 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201498—
+3K142876ACUSON S1000/ S2000/ S3000 Diagnostic Ultrasound SystemsSiemens Medical Solutions USA, Inc.2014581
+3K142395SC2000 and ACUSON X300 Diagnostic Ultrasound SystemsSiemens Medical Solutions USA, Inc.20140—
+3K141620RS80A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.2014101—
+4K250955XC11 ICE System, USAYorlabs, Inc.20250—
+4K2301796440 MyLabX90Esaote, S.p.A.202341
+4K213487ACUSON P500 Ultrasound SystemSiemens Medical Solutions USA, Inc.20221—
+4K210318Apogee 6500,Apogee 6300,Apogee 6200 Digital Color Doppler Ultrasound Imaging SystemShantou Institute of Ultrasonic Instruments Co., Ltd. (Siui)20210—
+4K202683ACUSON Sequoia Diagnostic Ultrasound System, ACUSON SC2000 Diagnostic Ultrasound System…Siemens Medical Solutions USA, Inc.20206—
+4K201130ACUSON Juniper Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.2020144
+4K1921576450 Ultrasound systemEsaote, S.p.A.20194—
+4K191922ACUSON P200 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.201923—
+4K182594E-CUBE i7Alpinion Medical Systems Co., Ltd.20191—
+4K182894HM70A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201910—
+4K182845minisonoAlpinion Medical Systems Co., Ltd.20180—
+4K1831916420 Ultrasound SystemEsaote, S.p.A.20180—
+4K181336HS50 / HS60 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201831—
+4K181617E-CUBE 8Alpinion Medical Systems Co., Ltd.20180—
+4K1808835D ViewerSamsung Medison Co., Ltd.20180—
+4K173713HS70A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201891
+4K180084Ultrasound System SONIMAGE MX1Konica Minolta, Inc.20181—
+4K173204RS85 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201839—
+4K173957ACUSON NX3 Diagnostic Ultrasound System; ACUSON NX3 ELITE Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.201882
+4K172732E-CUBE 8Alpinion Medical Systems Co., Ltd.201711—
+4K173000Apogee 2100 Digital Color Doppler Ultrasound Imaging System Apogee 2300 Digital Color…Shantou Institute of Ultrasonic Instruments Co., Ltd. (Siui)20173—
+4K173265UltraVision 2 Diagnostic Ultrasound SystemWinprobe Corporation20172—
+4K1725133D EchoJointvue, LLC20171—
+4K172374ACUSON NX2 Diagnostic Ultrasound System, ACUSON NX2 Elite Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.201712
+4K171070WS80A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201742—
+4K170493HS50 / HS60 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201737—
+4K170277DC-8/DC-8 PRO/DC-8 CV/DC-8 EXP/DC-8S Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.201720—
+4K163691HS70A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201758—
+4K161439E-CUBE 11Alpinion Medical Systems Co., Ltd.201612—
+4K152369ACUSON S1000, S2000, S3000 Diagnostic Ultrasuond SystemSiemens Medical Solutions USA, Inc. Ultrasound Group201554—
+5K2432536600 Ultrasound System (MyLabA50); 6600 Ultrasound System (MyLabA70)Esaote, S.p.A.20252—
+5K2416716450 Ultrasound System (MyLabE80); 6450 Ultrasound System (MyLabE85)Esaote, S.p.A.20252—
+5K243178Digital Color Doppler Ultrasound Imaging System (Apogee C1); Digital Color Doppler…Shantou Institute of Ultrasonic Instruments Co., Ltd.20250—
+5K243132Digital Color Doppler Ultrasound Imaging System (Readius L15); Digital Color Doppler…Shantou Institute of Ultrasonic Instruments Co., Ltd.20240—
+5K233610ACUSON P500 Ultrasound System; ACUSON P500 ICE Ultrasound SystemSiemens Medical Solutions USA, Inc.20240—
+5K221190ACUSON Juniper Diagnostic Ultrasound System and ACUSON Juniper Select Diagnostic…Siemens Medical Solutions USA, Inc.20224—
+5K220993Ultrasound System SONIMAGE MX1Konica Minolta, Inc.20220—
+5K212851EchoSK and EchoSGyn modules for EchoS Family devicesEcholight S.P.A20220—
+5K213523X-CUBE i8, X-CUBE i9Alpinion Medical Systems Co., Ltd.20220—
+5K211726Acuson SC2000 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.20214—
+5K2120216430 MyLabX75, 6430 MyLab XPro75Esaote, S.p.A.20210—
+5K210317Apogee 1000/ Apogee 1000Neo/ Apogee 1000Lite/ Apogee 1000Exp/ Apogee 1000B/W / Apogee…Shantou Institute of Ultrasonic Instruments Co., Ltd. (Siui)20210—
+5K2116563D Echo v1.1Jointvue, LLC20210—
+5K210743ACUSON Redwood Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.2021153
+5K200699HS70A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20200—
+5K192903RS85 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.202021—
+5K192505HS50/HS60 Diagnostics Ultrasound SystemSamsung Medison Co., Ltd.201910—
+5K192835ACUSON NX3 Diagnostic Ultrasound System / ACUSON NX3 Elite Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.20197—
+5K191055HS40 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20199—
+5K190039EchoSure Diagnostic Ultrasound SystemSonavex, Inc.20191—
+5K182932RS85 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201924—
+5K182595HERA W10 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201826—
+5K181277E-CUBE 12Alpinion Medical Systems Co., Ltd.20187—
+5K173981ACUSON NX2 Diagnostic Ultrasound System, ACUSON NX2 Elite Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. Ultrasound Group201802
+5K173471DC-80/DC-80 PRO/DC-80 EXP/DC-80S/DC-85 DiagnosticShenzhen Mindray Bio-Medical Electronics Co., Ltd.20181—
+5K171891ZS3 Ultrasound System, z.one pro Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.20174—
+5K172129HS40 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201735—
+5K171034M9 Diagnostic Ultrasound System, M9T Diagnostic Ultrasound System, M9CV Diagnostic…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.201712—
+5K162417Acuson Freestyle Ultrasound SystemSiemens Medi Cal Solutions, Inc.201629—
+5K162243ACUSON S1000 / S2000 / S3000 Diagnostic Ultrasound SystemSiemens Medi Cal Solutions, Inc.201649—
+6K2532886450 Ultrasound System (MyLabE80); 6450 Ultrasound System (MyLabE85)Esaote, S.p.A.20260—
+6K2533107600 Ultrasound System (MyLabC25); 7600 Ultrasound System (MyLabC30)Esaote, S.p.A.20250—