510(k) Report

Devices descending from K894632

405 later devices reach Model SSH-140A Ultrasound Imaging System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+10K250145Biopsy Port AdapterEndosound, Inc.20250—
+10K243937Accuro 3SRivanna Medical, Inc.20252—
+10K231267ClearTipFinemedix Co., Ltd.20231—
+10K223771Lumify Diagnostic Ultrasound SystemPhilips Ultrasound202322
+10K211321Wireless Probe Type Ultrasound Scanner (Model: CProbe; Type: Type C, Type L, Type CT…Guangzhou Sonostar Technologies Co., Ltd.20221—
+10K213488Bladder Scanner, Model Name:M5Suzhou Peaksonic Medical Technology Co., Ltd.20220—
+10K214089FUJIFILM Ultrasonic Processor SP-900 and FUJIFILM Ultrasonic Probe PB2020-M2Fujifilm Corporation20220—
+10K212400SONON Ultrasound Imaging System, Model: SONON 500LHealcerion Co., Ltd.20220—
+10K210468SC1 Handheld Ultrasound Imaging System (Model: SC1)Fcu Co., Ltd.20211—
+10K210476EchoTip Ultra Endoscopic Ultrasound Needle, EchoTip ProCore HD Ultrasound Biopsy Needle…Cook Ireland, Ltd.202121
+10K202035Vscan AirGE Medical Systems Ultrasound and Primary Care Diagnostics20203—
+10K200708Vivid iqGe Medical Systems Ultrasound And20203—
+10K193518KosmosEchoNous, Inc.20201—
+10K193517ViziShot 2 FLEXOlympus Surgical Technologies America20202Class I
+10K190669EndoticsEra Endoscopy S.R.L.20200—
+10K183516PENTAX Medical Ultrasound Video Bronchoscope EB19-J10UPentax of America, Inc.20191—
+10K191798Versana ActiveGE Medical Systems Ultrasound and Primary Care Diagnostics20191—
+10K191792Versana BalanceGE Medical Systems Ultrasound and Primary Care Diagnostics20193—
+10K183654PENTAX Medical EB-1970UK Ultrasound Video Bronchoscope + Hitachi NOBLUS and HI VISION…Pentax of America, Inc.20190—
+10K183085CoreDx™ Pulmonary Mini-ForcepsBoston Scientific Corporation20190—
+10K181934Vivid T8, Vivid T9GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC20183—
+10K1732916440 Ultrasound SystemEsaote, S.p.A.20188—
+10K173090Aplio i900/i800/i700/i600 Diagnostic Ultrasound System, V2.4Toshibamedical Systems Corporation201821—
+10K173768Tempus Pro Patient MonitorRemote Diagnostic Technologies, Ltd.20181—
+10K173085invendoscopy E210 SystemInvendo Medical GmbH20180—
+10K171956Sterile Endoscope Biopsy Sampling NeedleChangzhou Detain Medical Devices Co., Ltd.20170—
+10K173138Biim Diagnostic Ultrasound SystemBiim Ultrasound AS20170—
+10K172385Clarius Ultrasound SystemClarius Mobile Health Corp.201722—
+10K163443Interson USB Ultrasound SystemInterson Corporation20173—
+10K163469ViziShot 2 FLEXOlympus Surgical Technologies America20175—
+10K162549Lumify Ultrasound SystemPhilips Health Care2016436
+10K161119SonoSite iViz Ultrasound SystemFUJIFILM Sonosite, Inc.20164—
+10K131822Ultraextend Usws-900A V2.1 and V3.1Toshiba America Medical Systems, In.C20130—
+10K121577Aplio Artida Diagnostic Ultrasound SystemToshiba Medical Systems Corporation, Japan201229—
+10K110870Aplio Diagnostic Ultrasound System; Aplio Diagnostic Ultrasound System; Aplio Diagnostic…Toshiba America Medical Systems, In.C201189—
+10K1107464D LV-Analysis 3.0Tomtec Imaging Systems GmbH201180—
+10K091295Aplio XG Diagnostic Ultrasound System Model Ssa-790A Version 4.0Toshiba America Medical Systems, In.C2009222
+11K261274EchoTip Ultra® Endobronchial HD Ultrasound Biopsy Needle for Fujifilm Scopes; EchoTip…Cook Ireland, Ltd.20260—
+11K253452Accuro 3SRivanna Medical, Inc.20260—
+11K252558Lumify Diagnostic Ultrasound SystemPhilips Ultrasound, LLC20260—
+11K254021Accuro XVRivanna Medical, Inc.20260—
+11K252557Lumify Diagnostic Ultrasound SystemPhilips Ultrasound, LLC20250—
+11K251402LIA-1 Catheter (542-1)Leadoptik, Inc.20250—
+11K250994ClearTip FNA and FNB TypesFinemedix Co., Ltd.20250—
+11K234153EdgeLife Handheld Wireless Ultrasound System (E8200); EdgeLife Handheld Wireless…Edgelife Technologies, LLC20240—
+11K241209EchoTip AcuCore™ EUS Biopsy Needle (ECHO-BX-19)Cook Ireland, Ltd.20240—
+11K233579SC1 Handheld Ultrasound Imaging system (Model: SC1)Fcu Co., Ltd.20240—
+11K233734Interson USB Ultrasound SystemInterson Corporation20230—
+11K231354Pocket Ultrasound System (C10)Beijing Konted Medical Technology Co.,Ltd20232—
+11K2301796440 MyLabX90Esaote, S.p.A.202341
+11K232500Lumify Diagnostic Ultrasound SystemPhilips Ultrasound202301
+11K231301Vscan AirGE Medical Systems Ultrasound and Primary Care Diagnostics20231—
+11K230909EchoTip® AcuCore™ Ultrasound Biopsy Needle (ECHO-BX-3-22)Cook Ireland, Ltd.20231—
+11K213060AreusTM Endobronchial Ultrasound Aspiration Needle, TridentTM Endobronchial Ultrasound…Micro-Tech (Nanjing) Co., Ltd.20221—
+11K221148Vivid iqGE Medical Systems Ultrasound & Primary Care Diagnostics, LLC20222—
+11K220446Versana BalanceGE Medical Systems Ultrasound and Primary Care Diagnostics20221—
+11K212100KosmosEchoNous, Inc.202101
+11K203166PENTAX Medical Ultrasound Upper GI Video Scope EG34-J10U, PENTAX Medical Ultrasound…Pentax of America, Inc.20200—
+11K201746Tempus Pro Patient MonitorRemote Diagnostic Technologies Limited202007
+11K200851Vivid T8, Vivid T9GE Medical Systems Ultrasound and Primary Care Diagnostics20202—
+11K200998Versana ActiveGE Medical Systems Ultrasound and Primary Care Diagnostics20200—
+11K191235Leltek Ultrasound Imaging SystemLeltek, Inc.20209—
+11K192170VistaScan USB Ultrasound Imaging SystemEmagine Solutions Technology, LLC20200—
+11K190239Single Use Aspiration NeedleOlympus Medical Systems Corp.20192—
+11K1921576450 Ultrasound systemEsaote, S.p.A.20194—
+11K192573Dolphin Medical Imaging USB Ultrasound SystemDolphin Medical Imaging, LLC20190—
+11K191007Aixplorer MACH 30, Aixplorer MACH 20 Ultrasound Diagnostic SystemsSupersonic Imagine20195—
+11K192226Lumify Diagnostic Ultrasound SystemPhilips Health Care2019315
+11K1831916420 Ultrasound SystemEsaote, S.p.A.20180—
+11K182427Aplio a550 and a450, Software V2.8 Diagnostic Ultrasound SystemCanon Medical Systems Corporation20184—
+11K182679Aplio i900/i800/i700/i600 Diagnostic Ultrasound System, V3.1Canon Medical Systems Corporation201810—
+11K180799Clarius Ultrasound ScannerClarius Mobile Health Corp.201811—
+11K163510Poseidon Ultrasound SystemButterfly Network, Inc.201762
+11K162288SonoSite iViz Ultrasound SystemFUJIFILM Sonosite, Inc.20163—
+11K140729Aplio Artida, V3.2Toshiba America Medical Systems, In.C201428—
+11K132544Tomtec-Arena 1.0, Tomtec-Arena 3D Echo, Cardio-ArenaTomtec Imaging Systems GmbH201378—
+11K120282CardnavPaieon, Inc.20120—
+11K121076Ultraextend FX, Ultrasound Workstation PackageToshiba America Medical Systems, In.C20122—
+11K121422Aplio 500/400/300 Diagnostic Ultrasound SystemToshiba Medical Systems Coporation, Japan201285—
+11K100067Model Viamo Ssa-640A, Version 2.0 Ultrasound SystemToshiba America Medical Systems, In.C20101—
+11K093171Viamo Ssa-640A Version 1.2Toshiba America Medical Systems, In.C200911—
+11K092948Aplio MX Ssa-780A, Version 1.0Toshiba America Medical Systems, In.C200901
+11K092179Aplio XG Diagnostic Ultrasound System, Model Ssa - 790A Version 4.0R001Toshiba America Medical Systems, In.C200991
+12K261272ePascal S/ ePascal SOR/ ePascal S5/ ePascal SA/ ePascal SE/ ePascal 80Elite/ ePascal 80/…Esonic Technology (Wuhan) Co., Ltd.20260—
+12K251478ClearTip TBNA TypeFinemedix Co., Ltd.20260—
+12K251664Single Use Aspiration Needle (NA-201SX-4021); Single Use Aspiration Needle (NA-201SX-4022)Olympus Medical Systems Corporation20250—
+12K250913TINGSN FINDERS 2 Color Doppler Diagnostic Ultrasound SystemJiangsu Tingsn Technology Co., Ltd.20250—
+12K2432536600 Ultrasound System (MyLabA50); 6600 Ultrasound System (MyLabA70)Esaote, S.p.A.20252—
+12K2416716450 Ultrasound System (MyLabE80); 6450 Ultrasound System (MyLabE85)Esaote, S.p.A.20252—
+12K242519Lumify Diagnostic Ultrasound SystemPhilips Ultrasound20250Class I
+12K242670Lumify Diagnostic Ultrasound SystemPhilips Ultrasound20250Class I
+12K250087Vscan AirGE Medical Systems Ultrasound and Primary Care Diagnostics20250—
+12K250328UltraExtend NX CUW-U001S V2.0 Ultrasound Image Analysis ProgramCanon Medical Systems Corporation20250—
+12K243620Vivid iqGE Medical Systems Ultrasound and Primary Care Diagnostics20250—
+12K241979Pocket Ultrasound System (C10, C10TX, C10RL, C10RLpro)Beijing Konted Medical Technology Co.,Ltd20241—
+12K230778EndoCorePraxis Medical, LLC20230—
+12K223407Versana EssentialGE Medical Systems Ultrasound and Primary Care Diagnostics20230—
+12K221147Vivid T8, Vivid T9GE Medical Systems Ultrasound and Primary Care Diagnostics20221—
+12K210432LELTEK Ultrasound Imaging System (Model: LU700 Series)Leltek, Inc.20218—
+12K2120216430 MyLabX75, 6430 MyLab XPro75Esaote, S.p.A.20210—