510(k) Report

Devices descending from K945773

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+8K251673X9 Ultrasound SystemX9, Inc.20250—
+8K250026Shear Wave Quantificational Ultrasound Diagnostic System…Wuxi Hisky Medical Technologies Co., Ltd.20250—
+8K251106Sonosite LX and Sonosite PX Ultrasound SystemsFUJIFILM Sonosite, Inc.20250—
+8K251830Sonosite LX Ultrasound SystemFUJIFILM Sonosite, Inc.20251—
+8K243880Shear Wave Quantificational Ultrasound Diagnostic System (Mini900, Mini990, Mini800…Wuxi Hisky Medical Technologies Co., Ltd.20250—
+8K250328UltraExtend NX CUW-U001S V2.0 Ultrasound Image Analysis ProgramCanon Medical Systems Corporation20250—
+8K234153EdgeLife Handheld Wireless Ultrasound System (E8200); EdgeLife Handheld Wireless…Edgelife Technologies, LLC20240—
+8K233579SC1 Handheld Ultrasound Imaging system (Model: SC1)Fcu Co., Ltd.20240—
+8K240146BD Prevue™ II Peripheral Vascular Access SystemBard Access Systems, Inc.20240—
+8K233734Interson USB Ultrasound SystemInterson Corporation20230—
+8K231354Pocket Ultrasound System (C10)Beijing Konted Medical Technology Co.,Ltd20232—
+8K2301796440 MyLabX90Esaote, S.p.A.202341
+8K232988Aplio flex and Aplio go Software V2.0 Diagnostic Ultrasound SystemCanon Medical Systems Corporation20230—
+8K232500Lumify Diagnostic Ultrasound SystemPhilips Ultrasound202301
+8K231764Ultrasound System 1300Bk Medical Aps202301
+8K230066Carnation series Diagnostic Ultrasound SystemShenzhen Wisonic Medical Technology Co., Ltd.20230—
+8K231301Vscan AirGE Medical Systems Ultrasound and Primary Care Diagnostics20231—
+8K223917Vinno E20, Vinno E10,Vinno E10P,Vinno E10E, Vinno X1,Vinno X1E,Vinno X1P, Vinno X2,Vinno…Vinno Technology (Suzhou) Co.,Ltd20230—
+8K223570SonoAir Series Digital Color Doppler Ultrasound SystemCHISON Medical Technologies Co., Ltd.20230—
+8K221340iNod Ultrasound Guided Biopsy Needle (UPN: M00502060), iNod Ultrasound Guidance Console…Boston Scientific Corporation20230—
+8K221911Vinno 6PRO, Vinno 6EXP, Vinno 5PRO, Vinno 5EXP, Vinno 3, Vinno 3PRO, Vinno 3EXPVinno Technology (Suzhou) Co.,Ltd20220—
+8K222441Ultrasound System 2300Bk Medical Aps20221—
+8K221148Vivid iqGE Medical Systems Ultrasound & Primary Care Diagnostics, LLC20222—
+8K220446Versana BalanceGE Medical Systems Ultrasound and Primary Care Diagnostics20221—
+8K213487ACUSON P500 Ultrasound SystemSiemens Medical Solutions USA, Inc.20221—
+8K211886Clivia series Diagnostic Ultrasound SystemShenzhen Wisonic Medical Technology Co., Ltd.20211—
+8K210432LELTEK Ultrasound Imaging System (Model: LU700 Series)Leltek, Inc.20218—
+8K210318Apogee 6500,Apogee 6300,Apogee 6200 Digital Color Doppler Ultrasound Imaging SystemShantou Institute of Ultrasonic Instruments Co., Ltd. (Siui)20210—
+8K212100KosmosEchoNous, Inc.202101
+8K211859ACUSON Sequoia Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.202171
+8K203137Venue FitGE Medical Systems Ultrasound and Primary Care Diagnostics202051
+8K202233Venue GoGE Medical Systems Ultrasound and Primary Care Diagnostics202042
+8K202132VenueGE Medical Systems Ultrasound and Primary Care Diagnostics20207—
+8K203128Evis Eus Endoscopic Ultrasound Center Olympus EU-ME2/Evis Eus Endoscopic Ultrasound…Olympus Medical Systems Corp.20201—
+8K201990DC-30/DC-32/DC-28/DC-26/DC-25/DC-20/DC-30 Exp/DC-32 Exp Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.20200—
+8K201988T-LiteSonoscanner20201—
+8K202737Aplio i900/i800/i700/i600 Diagnostic Ultrasound System, Aplio a550, Aplio a450, and…Canon Medical Systems Corporation20200—
+8K202683ACUSON Sequoia Diagnostic Ultrasound System, ACUSON SC2000 Diagnostic Ultrasound System…Siemens Medical Solutions USA, Inc.20206—
+8K201746Tempus Pro Patient MonitorRemote Diagnostic Technologies Limited202007
+8K202406Butterfly iQ Ultrasound SystemButterfly Network, Inc.20205—
+8K200851Vivid T8, Vivid T9GE Medical Systems Ultrasound and Primary Care Diagnostics20202—
+8K200138Versana PremierGe Medical Systems Ultrasound And20202—
+8K200998Versana ActiveGE Medical Systems Ultrasound and Primary Care Diagnostics20200—
+8K201130ACUSON Juniper Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.2020144
+8K201062syngo Ultrasound Apps Suite (sUSAS)Siemens Medical Solutions USA, Inc.20200—
+8K200411Z6/Z60/Z60T/Z60S/Z60 Pro/DP-60 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.20200—
+8K191347Paragon XHD Diagnostic Ultrasound SystemShenzhen Wisonic Medical Technology Co., Ltd.20200—
+8K192170VistaScan USB Ultrasound Imaging SystemEmagine Solutions Technology, LLC20200—
+8K1921576450 Ultrasound systemEsaote, S.p.A.20194—
+8K192573Dolphin Medical Imaging USB Ultrasound SystemDolphin Medical Imaging, LLC20190—
+8K191007Aixplorer MACH 30, Aixplorer MACH 20 Ultrasound Diagnostic SystemsSupersonic Imagine20195—
+8K192226Lumify Diagnostic Ultrasound SystemPhilips Health Care2019315
+8K192107Clarius Ultrasound ScannerClarius Mobile Health Corp.201910—
+8K191922ACUSON P200 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.201923—
+8K191467Aplio i900/i800/i700/i600 Diagnostic Ultrasound System, V4.0Canon Medical Systems Corporation20199—
+8K183041Full Digital Colour Doppler Ultrasonic Diagnostic SystemWuhan Zoncare Bio-medical Electronics Co., Ltd.20190—
+8K183377DC-40/DC-35/DC-45/DC-40S/DC-40 Pro Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.20190—
+8K181637DC-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—
+8K182427Aplio a550 and a450, Software V2.8 Diagnostic Ultrasound SystemCanon Medical Systems Corporation20184—
+8K182679Aplio i900/i800/i700/i600 Diagnostic Ultrasound System, V3.1Canon Medical Systems Corporation201810—
+8K181617E-CUBE 8Alpinion Medical Systems Co., Ltd.20180—
+8K180974CBit Series Digital Color Doppler Ultrasound SystemCHISON Medical Technologies Co., Ltd.20183—
+8K180912TE7/TE5 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.201811—
+8K173780EchoMD Automated Ejection Fraction SoftwareBay Labs, Inc.201810—
+8K180409HS40 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201834—
+8K180461Navi e/Navi s/Navi X Diagnostic Ultrasound SystemShenzhen Wisonic Medical Technology Co., Ltd.20181—
+8K173962Viamo c100 TUS-VC100 Diagnostic Ultrasound SystemToshibamedical Systems Corporation20180—
+8K180408U60 Diagnostic Ultrasound SystemEdan Instruments, Inc.20180—
+8K173513WS80A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.2018321
+8K173204RS85 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201839—
+8K171207FUJIFILM Ultrasonic Processor SP-900 and FUJIFILM Ultrasonic Probe PB2020-MFujifilm Medical Systems U.S.A, Inc.20181—
+8K173471DC-80/DC-80 PRO/DC-80 EXP/DC-80S/DC-85 DiagnosticShenzhen Mindray Bio-Medical Electronics Co., Ltd.20181—
+8K172732E-CUBE 8Alpinion Medical Systems Co., Ltd.201711—
+8K173000Apogee 2100 Digital Color Doppler Ultrasound Imaging System Apogee 2300 Digital Color…Shantou Institute of Ultrasonic Instruments Co., Ltd. (Siui)20173—
+8K173265UltraVision 2 Diagnostic Ultrasound SystemWinprobe Corporation20172—
+8K172607Philips EPIQ 5 Diagnostic Ultrasound System, EPIQ 7 Diagnostic Ultrasound System…Philips Health Care20172831
+8K171891ZS3 Ultrasound System, z.one pro Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.20174—
+8K171233Resona 7/Resona 7CV/Resona 7EXP/Resona 7S/Resona 7OB Diagnostic Ultrasound SystemShenzhen Mindray Bio-Meidcal Electronics Co., Ltd.201721—
+8K163510Poseidon Ultrasound SystemButterfly Network, Inc.201762
+8K171048RS80A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201750—
+8K172162ACUSON S3000 S2000 S1000 Diagnostic Ultrasound SystemsSiemens Healthcare201743—
+8K172374ACUSON NX2 Diagnostic Ultrasound System, ACUSON NX2 Elite Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.201712
+8K171824Acclarix AX8 Diagnostic Ultrasound System, Acclarix LX8 Diagnostic Ultrasound SystemEdan Instruments, Inc.20177—
+8K171034M9 Diagnostic Ultrasound System, M9T Diagnostic Ultrasound System, M9CV Diagnostic…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.201712—
+8K170878Vivid S60N, Vivid S70NGE Medical Systems Ultrasound & Primary Care Diagnostics, LLC2017102
+8K170823Vivid E80, Vivid E90, Vivid E95GE Medical Systems Ultrasound and Primary Care Diagnostics2017353
+8K171314QLAB Advanced Quantification SoftwarePhilips Health Care201745—
+8K170521Trinity/3D Prostate SuiteKoelis20170—
+8K163119NaviSuite SSI EditionMedcom GmbH20171—
+8K170069AmCAD-UVAmcad Biomed Corporation20170—
+8K170445Logiq S8GE Healthcare2017191
+8K163691HS70A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201758—
+8K163596LOGIQ P9 and LOGIQ P7GE Healthcare201747—
+8K162902ARIETTA Prologue Diagnostic Ultrasound system and TransducersHitachi, Ltd.20160—
+8K162065Ultrasound System SONIMAGE HS1Konica Minolta, Inc.201622
+8K160559NOBLUS™ Ultrasound Diagnostic SystemHitachi Medical Corporation201601
+8K153539RS80A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201659—
+8K162221ACUSON SC2000 Diagnostic Ultrasound SystemSiemens Medical Solutions Inc. Ultrasound Group2016481
+8K162094RS80A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201664—
+8K152126Ust-5550-R; Ust-5536-R; L43KHitachi Aloka Medical America, Inc.201601