510(k) Report

Devices descending from K934915

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+11K182932RS85 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201924—
+11K182594E-CUBE i7Alpinion Medical Systems Co., Ltd.20191—
+11K182845minisonoAlpinion Medical Systems Co., Ltd.20180—
+11K182595HERA W10 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201826—
+11K181336HS50 / HS60 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201831—
+11K182715Piloter Exp/Piloter/Piloter P Diagnostic Ultrasound SystemShenzhen Wisonic Medical Technology Co., Ltd.20180—
+11K181277E-CUBE 12Alpinion Medical Systems Co., Ltd.20187—
+11K180737Ultrasound Scanner System bk2300Bk Medical Aps20182—
+11K181485EPIQ , EPIQ 5, EPIQ 7, Affiniti 30, Affiniti 50 and Affiniti 70 Diagnostic Ultrasound…Philips Ultrasound, Inc.20182724
+11K181547FibroScan® Family of Products (Models: 502 Touch, 530 Compact, and 430 Mini+)Echosens201814—
+11K180862Acclarix LX8 Diagnostic Ultrasound System, Acclarix AX8 Diagnostic Ultrasound SystemEdan Instruments, Inc.20183—
+11K1808835D ViewerSamsung Medison Co., Ltd.20180—
+11K173713HS70A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201891
+11K173569Ultrasound System 1300Bk Medical Aps20181—
+11K180084Ultrasound System SONIMAGE MX1Konica Minolta, Inc.20181—
+11K173981ACUSON NX2 Diagnostic Ultrasound System, ACUSON NX2 Elite Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. Ultrasound Group201802
+11K173768Tempus Pro Patient MonitorRemote Diagnostic Technologies, Ltd.20181—
+11K172860Resona 6/Resona 6T/Resona 6EXP/Resona 6Elite Diagnostic Ultrasound System/Resona…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20180—
+11K171708Aloka Arietta 850Hitachi Healthcare Americas Corporation201781
+11K171926C5 Diagnostic Ultrasound SystemGuangzhou Sonostar Technologies Co., Ltd.20171—
+11K1725133D EchoJointvue, LLC20171—
+11K172055DUS-7000 Digital Color Doppler Ultrasound SystemAdvanced Instrumentations, Inc.20170—
+11K171900Acclarix AX4 Diagnostic Ultrasound SystemEdan Instruments, Inc.20172—
+11K171070WS80A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201742—
+11K171766Acuson SC2000 Diagnostic Ultrasound SystemSiemens Medi Cal Solutions, Inc.201720—
+11K163505Arietta PrecisionHitachi, Ltd.20170—
+11K163443Interson USB Ultrasound SystemInterson Corporation20173—
+11K170493HS50 / HS60 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201737—
+11K163691HS70A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201758—
+11K162583Aloka Lisendo 880Hitachi, Ltd.201602
+11K163020Xperius Ultrasound SystemPhilips Health Care201611
+11K162549Lumify Ultrasound SystemPhilips Health Care2016436
+11K161439E-CUBE 11Alpinion Medical Systems Co., Ltd.201612—
+11K162329CX50 Diagnostic Ultrasound System, Sparq Diagnostic Ultrasound SystemPhilips Health Care2016273
+11K162243ACUSON S1000 / S2000 / S3000 Diagnostic Ultrasound SystemSiemens Medi Cal Solutions, Inc.201649—
+11K152854S50 Digital Color Doppler Ultrasound SystemSonoscape Medical Corp.201616—
+11K152195Logiq S8GE Healthcare201557—
+11K152309LOGIQ E9, LOGIQ E9 XDClear 2.0GE Medical Systems Ultrasound and Primary Care Diagnostics20151001
+11K152396S12 Digital Color Doppler Ultrasound SystemSonoscape Medical Corp.20151—
+11K152164S8 Exp/S9 Pro Portable Digital Color Doppler Ultrasound SystemSonoscape Medical Corp.20153—
+11K152165S9 Portable Digital Color Doppler Ultrasound SystemSonoscape Medical Corp.201502
+11K151060Ultrasound System SONIMAGE HS1Konica Minolta, Inc.201541
+11K150949FibroScanEchosens201542—
+11K151175ZONARE ZS3 Diagnostic Ultrasound SystemZonare Medical Systems, Inc.201519—
+11K150087Vivid E80 Diagnostic Ultrasound Imaging System, Vivid E90 Diagnostic Ultrasound Imaging…Ge Vingmed Ultrasound AS2015736
+11K142323Vivid S60 Diagnostic Ultrasound System, Vivid S70 Diagnostic Ultrasound SystemGe Medical Systems Israel, Ltd.2014843
+11K141261Logiq S7 Expert, Logiq S7 ProGE Healthcare2014144—
+11K133761Aplio 500/400/300 Diagnostic Ultrasound System V4.0Toshibamedical Systems Corporation201472—
+11K131507Xario 200 Diagnostic Ultrasound SystemToshibamedical Systems Corporation20139—
+11K131527Logiq S8GE Healthcare2013219—
+11K131514GE Vivid E9 Diagnostic Ultrasound Imaging SystemGe Vingmed Ultrasound AS20131672
+11K122921C1-6-D Ultrasound TransducerGE Healthcare20120—
+11K122327Voluson E6/E8/E8EXPERT/E10GE Healthcare2012365—
+11K122515C2-9-D Ultrasound TransducerGE Healthcare20120—
+11K120741Voluson S6, Voluson S8GE Healthcare2012295—
+11K113690GE Logiq I, Logiq E and Vivid EGE Healthcare20114691
+12K262390BoneXpertVisiana20260—
+12K253452Accuro 3SRivanna Medical, Inc.20260—
+12K252558Lumify Diagnostic Ultrasound SystemPhilips Ultrasound, LLC20260—
+12K261132Healium Intelliscan LX192LCHealium Intelliscan Corporation20260—
+12K254021Accuro XVRivanna Medical, Inc.20260—
+12K254099EVO Q30 Diagnostic Ultrasound System; EVO Q20 Diagnostic Ultrasound System; EVO Q10…Samsung Medison Co., Ltd.20261—
+12K253593Clarius Ejection Fraction AIClarius Mobile Health Corp.20260—
+12K252557Lumify Diagnostic Ultrasound SystemPhilips Ultrasound, LLC20250—
+12K250914MediAI-BACrescom Co., Ltd.20250—
+12K251601Hepatus 7/Hepatus 6/Hepatus 5/Hepatus 7S/Hepatus 6S/Hepatus 5S/Hepatus7T/Hepatus…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20250—
+12K251820ViewMateTM Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.20250—
+12K250381Deepsight NeedleVue LC1 Ultrasound SystemDeepSight Technology, Inc.20250—
+12K250087Vscan AirGE Medical Systems Ultrasound and Primary Care Diagnostics20250—
+12K250030Flash Ultrasound System 5100 Point of CarePhilips Ultrasound, LLC202505
+12K243479EchoGuide (Version 1)Sonavex, Inc.20250—
+12K243298Venus Ultimate-Dual, Venus Ultimate-Hepa, Venus Ultimate-Uro Diagnostic Ultrasound SystemCarbon (Shenzhen) Medical Device Co., Ltd.20250—
+12K242223SuperSonic HepaVuSupersonic Imagine20240—
+12K233697SonoMax Series Digital Color Doppler Ultrasound SystemCHISON Medical Technologies Co., Ltd.20241—
+12K240704ACUSON Sequoia Diagnostic Ultrasound System, ACUSON Sequoia Select Diagnostic Ultrasound…Siemens Medical Solutions USA, Inc.20243—
+12K240684Resona I9, Resona I9 Exp, Resona I9S, Resona I9T, Resona I9 Easi, Resona I9 Nasa, Resona…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20240—
+12K232331InVision Precision LVEF (LVEF)InVision Medical Technology Corporation20240—
+12K240115Resona I8W, Resona I8, Resona I8 Exp, Resona I8S, Resona I8T, Resona IY,Resona I8 Easi…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20240—
+12K233788EPIQ Series Diagnostic Ultrasound System, Affiniti Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC2024161
+12K233734Interson USB Ultrasound SystemInterson Corporation20230—
+12K231354Pocket Ultrasound System (C10)Beijing Konted Medical Technology Co.,Ltd20232—
+12K231965Voluson Expert 22, Voluson Expert 20, Voluson Expert 18GE Medical Systems Ultrasound and Primary Care Diagnostics20232—
+12K232500Lumify Diagnostic Ultrasound SystemPhilips Ultrasound202301
+12K230511K3900 Ultrasound Imaging SystemMaui Imaging20230—
+12K231764Ultrasound System 1300Bk Medical Aps202301
+12K230768M9/M9CV/M9T/M8 Elite/M10/M10CV/Crius M10/M11/M11CV/Crius M11/Operus M11/M9 Premium…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20231—
+12K223832Vivid S60N, Vivid S70NGe Medical System Ultrasound and Primary Care Diagnostics202312
+12K222928Resona R9/ Resona R9 Exp/ Resona R9 Pro/ Resona R9S/ Nuewa R9/ Nuewa R9 Exp Diagnostic…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20233—
+12K222441Ultrasound System 2300Bk Medical Aps20221—
+12K222754ViewMate Multi Ultrasound SystemShenzhen Mindray Bio-Meidcal Electronics Co., Ltd.20221—
+12K220882Vivid E80, Vivid E90, Vivid E95Ge Medical Systems Ultrasound And20222—
+12K220993Ultrasound System SONIMAGE MX1Konica Minolta, Inc.20220—
+12K213862HD60 Series Ultrasound Diagnostic SystemQingdao Hisense Medical Equipment Co., Ltd.20223—
+12K220242TEX20/TEX20 Pro/TEX20S/TEX20T/TEX20 Exp/TEX20 Elite, TEX10/ TEX10…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20221—
+12K212960Aplio a550, Aplio a450, and Aplio a, Diagnostic Ultrasound System, Software V6.5Canon Medical Systems Corporation202201
+12K213523X-CUBE i8, X-CUBE i9Alpinion Medical Systems Co., Ltd.20220—
+12K212333Aplio i900/i800/i700 Diagnostic Ultrasound System, Software V6.5Canon Medical Systems Corporation202261
+12K212265TEX20/TEX20 Pro/TEX20S/TEX20T/TEX20 Exp/TEX20 Elite Diagnostic Ultrasound System, TEX10/…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20216—
+12K212900MX7/MX7T/Vaus7/Zeus/ME7/Anesus ME7/Anesus ME7T/MX8/MX8T/Vaus8/ME8 Diagnostic Ultrasound…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20217—
+12K2116563D Echo v1.1Jointvue, LLC20210—