510(k) Report

Devices descending from K945773

1,030 later devices reach Siemens Sonoline Versa through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+9K203391TE7/TE5/TE7 Max/TE5 Max/TE9 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.20217—
+9K201965SonoEye P1/ SonoEye P1-G/ SonoEye V1/ SonoEye V1-G/ SonoEye G1/ SonoEye G1-G Digital…CHISON Medical Technologies Co., Ltd.20210—
+9K201967SonoEye P2/ SonoEye V2/ SonoEye G2 Digital Color Doppler Palm Ultrasound SystemCHISON Medical Technologies Co., Ltd.20210—
+9K201968SonoEye P3/ SonoEye V3/ Sono Eye G3 Digital Color Doppler Palm Ultrasound SystemCHISON Medical Technologies Co., Ltd.20210—
+9K201971SonoEye P5/ SonoEye V5/ SonoEye G5 Digital Color Doppler Palm Ultrasound SystemCHISON Medical Technologies Co., Ltd.20210—
+9K201969SonoEye P6/ SonoEye V6/ SonoEye G6 Digital Color Doppler Palm Ultrasound SystemCHISON Medical Technologies Co., Ltd.20210—
+9K203406Lumify Diagnostic Ultrasound SystemPhilips Ultrasound, Inc.202143
+9K202455Aixplorer®MACH20, Aixplorer®MACH30, Supersonic MACH40, Supersonic MACH30 & Supersoinc…Supersonic Imagine20200—
+9K202074Apache Ultrasound System (Model C62)Compal Electronics, Inc.20200—
+9K201972Aplio i900/i800/i700 Diagnostic Ultrasound System, Software V5.1Canon Medical Systems Corporation20207—
+9K200780XBit Series Digital Color Doppler Ultrasound SystemCHISON Medical Technologies Co., Ltd.20202—
+9K200643Hepatus 7/Hepatus 6/Hepatus 5/Hepatus 7S/Hepatus 6S/Hepatus 5S/Hepatus 7T/Hepatus…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20201—
+9K200621Caption Interpretation Automated Ejection Fraction SoftwareCaption Health202031
+9K201462ACUSON Sequoia Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.2020241
+9K200232LVivo Software ApplicationDia Imaging Analysis, Ltd.202019—
+9K201012EPIQ Diagnostic Ultrasound System Series, Affiniti Diagnostic Ultrasound System Series…Philips Ultrasound, Inc.2020185
+9K200707ACUSON Sequoia Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.202025—
+9K200001MX7/ MX7T/ Vaus7/ Zeus Diagnostic Ultrasound System, ME7/ Anesus ME7/ Anesus ME7T…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20208—
+9K192372ASCEND Image ViewerAscend Hit20200—
+9K193257ACUSON Sequoia Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.2020261
+9K192410ZS3 and z.one pro Ultrasound SystemsShenzhen Mindray Bio-Medical Electronics Co., Ltd.20193—
+9K192152DC-80/DC-80 PRO/DC-80 EXP/DC-80S/DC-85/DC-86/DC-86S/DC-89/DC-TV/DC-TQ Diagnostic…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20196—
+9K191493Ventripoint Medical System Plus (VMS+) 3.0Ventripoint Diagnostics, Ltd.20191—
+9K191663Aplio a550, Aplio a450 and Aplio a, Diagnostic Ultrasound System, V4.0Canon Medical Systems Corporation20193—
+9K191055HS40 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20199—
+9K190039EchoSure Diagnostic Ultrasound SystemSonavex, Inc.20191—
+9K190206DC-90/DC-90S/DC-90Q/DC-95/DC-95S/DC-88/DC-88S/DC-80A/DC-80A Exp/DC-80A…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20190—
+9K182932RS85 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201924—
+9K182594E-CUBE i7Alpinion Medical Systems Co., Ltd.20191—
+9K182894HM70A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201910—
+9K182632HS30 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20191—
+9K182845minisonoAlpinion Medical Systems Co., Ltd.20180—
+9K1827504D ViewGE Medical Systems Ultrasound and Primary Care Diagnostics20180—
+9K182595HERA W10 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201826—
+9K181336HS50 / HS60 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201831—
+9K182715Piloter Exp/Piloter/Piloter P Diagnostic Ultrasound SystemShenzhen Wisonic Medical Technology Co., Ltd.20180—
+9K182450Vivid S60N, Vivid S70NGE Medical Systems Ultrasound and Primary Care Diagnostics201892
+9K181277E-CUBE 12Alpinion Medical Systems Co., Ltd.20187—
+9K181783Logiq P9; Logiq P7GE Healthcare2018171
+9K181485EPIQ , EPIQ 5, EPIQ 7, Affiniti 30, Affiniti 50 and Affiniti 70 Diagnostic Ultrasound…Philips Ultrasound, Inc.20182724
+9K181547FibroScan® Family of Products (Models: 502 Touch, 530 Compact, and 430 Mini+)Echosens201814—
+9K181264QLAB Advanced Quantification SoftwarePhilips Ultrasound, Inc.201844—
+9K180862Acclarix LX8 Diagnostic Ultrasound System, Acclarix AX8 Diagnostic Ultrasound SystemEdan Instruments, Inc.20183—
+9K1808835D ViewerSamsung Medison Co., Ltd.20180—
+9K173713HS70A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201891
+9K180084Ultrasound System SONIMAGE MX1Konica Minolta, Inc.20181—
+9K180067ACUSON X800 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.201828—
+9K173981ACUSON NX2 Diagnostic Ultrasound System, ACUSON NX2 Elite Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. Ultrasound Group201802
+9K172860Resona 6/Resona 6T/Resona 6EXP/Resona 6Elite Diagnostic Ultrasound System/Resona…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20180—
+9K173341Vivid E80, Vivid E90, Vivid E95GE Medical Systems2017203
+9K171708Aloka Arietta 850Hitachi Healthcare Americas Corporation201781
+9K171926C5 Diagnostic Ultrasound SystemGuangzhou Sonostar Technologies Co., Ltd.20171—
+9K172342Voluson E6, Voluson E8, Voluson E10GE Healthcare201718—
+9K1725133D EchoJointvue, LLC20171—
+9K172055DUS-7000 Digital Color Doppler Ultrasound SystemAdvanced Instrumentations, Inc.20170—
+9K171900Acclarix AX4 Diagnostic Ultrasound SystemEdan Instruments, Inc.20172—
+9K171070WS80A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201742—
+9K170841BiopSee, Mobile USMedcom GmbH20170—
+9K170847EchoPAC Software Only, EchoPAC Plug-inGE Medical Systems Ultrasound and Primary Care Diagnostics20174—
+9K163505Arietta PrecisionHitachi, Ltd.20170—
+9K170078Medisono Color Doppler Ultrasound System, models P11 Portable, P11 EXPERT Portable, P12…Medisono, LLC20170—
+9K170315Acuson SC2000 Diagnostic Ultrasound SystemSiemens Medi Cal Solutions, Inc.2017451
+9K170493HS50 / HS60 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201737—
+9K162583Aloka Lisendo 880Hitachi, Ltd.201602
+9K163077LOGIQ E9, LOGIQ E9 XDClear 2.0GE Medical Systems Ultrasound and Primary Care Diagnostics201673—
+9K163020Xperius Ultrasound SystemPhilips Health Care201611
+9K162269Voluson E6, Voluson E8, Voluson E10GE Healthcare201641—
+9K162417Acuson Freestyle Ultrasound SystemSiemens Medi Cal Solutions, Inc.201629—
+9K161439E-CUBE 11Alpinion Medical Systems Co., Ltd.201612—
+9K162329CX50 Diagnostic Ultrasound System, Sparq Diagnostic Ultrasound SystemPhilips Health Care2016273
+9K162243ACUSON S1000 / S2000 / S3000 Diagnostic Ultrasound SystemSiemens Medi Cal Solutions, Inc.201649—
+9K160078Vivid T8Ge Medical Systems Ultrasound and Primary Care Diagnotics, L201618—
+9K160184Voluson S6, Voluson S8, Voluson S10GE Healthcare2016551
+9K152396S12 Digital Color Doppler Ultrasound SystemSonoscape Medical Corp.20151—
+9K152164S8 Exp/S9 Pro Portable Digital Color Doppler Ultrasound SystemSonoscape Medical Corp.20153—
+9K152165S9 Portable Digital Color Doppler Ultrasound SystemSonoscape Medical Corp.201502
+9K150949FibroScanEchosens201542—
+9K150045S30/S40 Digital Color Doppler Ultraound SystemSonoscape Company Limited201517—
+9K150122Tomtec-Arena TTA2Tomtec Imaging Systems GmbH2015561
+9K141768Logiq V5/Logiq V3GE Healthcare201457—
+9K141675Voluson P6, Voluson P8GE Healthcare201414—
+9K141067Vivid T8/Vivid T8 ProGE Healthcare201419—
+9K133761Aplio 500/400/300 Diagnostic Ultrasound System V4.0Toshibamedical Systems Corporation201472—
+9K132913Voluson E6 / E8 / E8EXPERT / E8EXPERT Limited Edition / E10GE Healthcare2013255—
+9K131507Xario 200 Diagnostic Ultrasound SystemToshibamedical Systems Corporation20139—
+9K131158CorviewMarrek, Inc.20130—
+10K261081Pocket Ultrasound System (C10MTpro,C10MXpro,C10MSpro,C10MBpro,C10MRpro)Beijing Konted Medical Technology Co.,Ltd20260—
+10K2532886450 Ultrasound System (MyLabE80); 6450 Ultrasound System (MyLabE85)Esaote, S.p.A.20260—
+10K251268Diagnostic Ultrasound System (Nano C5, Nano C5 EXP, Nano L12, and Nano L12 EXP)Edan Instruments, Inc.20250—
+10K250791ASUS Ultrasound Imaging System (LU800 series)Asustek Computer, Inc.20250—
+10K251601Hepatus 7/Hepatus 6/Hepatus 5/Hepatus 7S/Hepatus 6S/Hepatus 5S/Hepatus7T/Hepatus…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20250—
+10K2533107600 Ultrasound System (MyLabC25); 7600 Ultrasound System (MyLabC30)Esaote, S.p.A.20250—
+10K252105Ligence HeartLigence Uab20250—
+10K251820ViewMateTM Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.20250—
+10K251342EchoPAC Software Only / EchoPAC Plug-inGE Medical Systems Ultrasound and Primary Care Diagnostics20251—
+10K250120GECHONarnar, LLC20250—
+10K250670EchoConfidence (USA)Mycardium AI Limited20250—
+10K250030Flash Ultrasound System 5100 Point of CarePhilips Ultrasound, LLC202505
+10K243298Venus Ultimate-Dual, Venus Ultimate-Hepa, Venus Ultimate-Uro Diagnostic Ultrasound SystemCarbon (Shenzhen) Medical Device Co., Ltd.20250—
+10K242893VERAFEYE System VERAFEYE Imaging Catheter & VERAFEYE Imaging SystemLuma Vision Limited20252—