510(k) Report

Devices descending from K933743

747 later devices reach SSA-380A through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K991858Ssa-390A/Power Vision 8000Toshiba America Medical Systems, In.C1999212—
+1K991710Ssa-370A/Powervision 6000Toshiba America Medical Systems, In.C1999203—
+1K974813Combison 530D with Power Doppler ModeMedison America, Inc.1998211—
+1K964865PVK-720ST Endocavitary TransducerToshiba America Medical Systems, In.C1997204—
+1K970047Phased Array Transducer - - PSK-20CTToshiba America Medical Systems, In.C1997403—
+1K963705Color Enhancement Function for the Ssa-380AToshiba America Medical Systems, In.C1996403—
+1K954028HP Sonos Ultrasound Imaging SystemHewlett-Packard Co.19961922
+2K051334Terason Ultrasound System with Continuous Wave SopplerTeratech Corp.20055—
+2K013633Ssa-770A, Aplio Ultrasound SystemToshiba America Medical Systems, In.C2001211—
+2K994096Sonoheart Hand-Carried Echocardiography SystemSonosite,Inc.1999196—
+2K992761Sonoace 5500 Diagnostic Ultrasound SystemMedison America, Inc.199933—
+2K984639The S-Vna 5-8(B) Diagnostic Ultrasound TransducerMedison America, Inc.19990—
+2K992155Volusion Small Parts Transducer, Model S-VNW 5-10, Volusion Abdominal Transducer, Model…Medison America, Inc.1999208—
+2K990400Linear Array Transducer,Model HP 21376, M2410A Ultrasound Imaging SystemHewlett-Packard Co.19990—
+2K972348HP Endovaginal/Endorectal Probe, HP Image Point Ultrasound SystemHewlett-Packard Co.19971901
+3K082147Bodymetrix BX2000Intelametrix, Inc.20092—
+3K072266Acuson P50 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.20071—
+3K063761Acuson P10 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.2007135—
+3K032281Ssa-770A - Version 4, Aplio Diagnostic Ultrasound SystemToshiba America Medical Systems, In.C2003209—
+3K022400Ssa-700A, Aplio Diagnostic Ultrasound SystemToshiba America Medical Systems, In.C20022101
+3K012887SA6000II Diagnostic Ultrasound SystemMedison America, Inc.200132—
+3K010591Olympus EU-C60 Eus Exera Compact Endoscopic Ultrasound CenterOlympus Optical Co., Ltd.2001592
+3K002185Sonoace SA 9900 Diagnostic Ultrasound SystemMedison America, Inc.20002071
+3K990339Sonos 5500 Imaging System M2424A Version B.OHewlett-Packard Co.19991891
+4K202514EchoS FamilyEcholight S.P.A20211—
+4K130659Speqrt Ultrasound SystemSignostics Pty, Ltd.20134—
+4K092756GE Vscan Compact Diagnostic Ultrasound SystemGe Vingmed Ultrasound AS2009130—
+4K090505Speq Ultrasound SystemSignostics Pty, Ltd.2009107—
+4K083114Acuson P50 Ultrasound SystemSiemens Medical Solutions USA, Inc.20090—
+4K072164DC-6 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.2007188—
+4K063683Olympus Xeu-M60A Endoscopic Ultrasound Center; XGF-UM180 Ultrasonic GastrovideoscopeOlympus Medical Systems Corporation200715—
+4K063130Aplio XG Diagnostic Ultrasound System, Model Ssa-790A, Version 1.0Toshibamedical Systems Corporation20062051
+4K053530Sonoace X4 Diagnostic Ultrasound SystemMedison Co., Ltd.20060—
+4K052911Accuvix XQ Diagnostic Ultrasound SystemMedison Co., Ltd.2005131—
+4K043588Mylab 15 / Mylab 20, Model 2700Pie Medical200530—
+4K042140Olympus BF Type UC160-OL8Olympus Corporation2004431
+4K041499Ssa-770A, Aplio Version 5.5Toshibamedical Systems Corporation200423
+4K032329SA 9900 Plus Diagnostic Ultrasound SystemMedison America, Inc.2003132—
+4K031552Mycolor 202 Diagnostic Ultrasound System and TransducersMedison America, Inc.20031845
+4K031347Ultrasonic Gastrovideoscope, Type UC160P-AT8 and UCT160-AT8Olympus Optical Co., Ltd.200344—
+4K013627Sonoace SA-8000 Diagnostic Ultrasound SystemMedison America, Inc.2001204—
+5K212851EchoSK and EchoSGyn modules for EchoS Family devicesEcholight S.P.A20220—
+5K173595Shear Wave Quantificational Ultrasound Diagnostic SystemWuxi Hisky Medical Technologies Co., Ltd.20183—
+5K160420SpeqTSignostics Limited20161—
+5K152250SpeqRTSignostics Limited20150—
+5K142511U50 Diagnostic Ultrasound SystemEdan Instruments, Inc.201513—
+5K143493SignosRT Bladder Ultrasound SystemSignostics, Ltd.20150—
+5K140693Vscan with Dual ProbeGe Medical Sysyems Ultrasound & Primary Care Diagn201429—
+5K131830Digital Ultrasonic Diagnostic Imaging SystemEdan Instruments, Inc.20131—
+5K123249Diagnostic Ultrasound SystemEdan Instruments, Inc.201321—
+5K121564Endoscopic Ultrasound Center EU-Y0006Olympus Medical Systems Corp.20126—
+5K121035Fujinon/Fujifilm Ultrasonic Endoscope EB-530USFujifilm Medical System U.S.A., Inc.20122—
+5K102153Mobius Ultrasound Imaging SystemMobisante, Inc.2011103—
+5K102991M5 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.2010128—
+5K092691DC-7 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.2009176—
+5K092156Cad 12, Colonoscopy Assist DeviceSoftscope Medical Technologies, Inc.20097—
+5K092159Accuvix V20 Diagnostic Ultrasound SystemMedison Co., Ltd.2009123—
+5K091941DC-3/DC-3T Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.2009177—
+5K090912Digital Ultrasonic Diagnostic Imaging System, Model DP-6900Shenzhen Mindray Bio-Medical Electronics Co., Ltd.2009114—
+5K083505DC-3/DC-3T Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.2008178—
+5K083001M5 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.2008179—
+5K081320DC-3, DC-3T Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.2008180—
+5K080640M5 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.2008182—
+5K072826Aplio Artida Diagnostic Ultrasound SystemToshiba America Medical Systems, In.C2007182—
+5K072000Aplio XG Diagnostic Ultrasound System, Model Ssa-790A Version 2.0Toshiba America Medical Systems, In.C2007203—
+5K070983Olympus XBF-UC180F-DT8 Ultrasonic Bronchofibervideoscope Used with Aloka SSD-Alpha 5/10…Olympus Medical Systems Corporation2007113
+5K070903MYLAB40Esaote Europe B.V.200727—
+5K070813Accuvix V10 Diagnostic Ultrasound SystemMedison Co., Ltd.2007125—
+5K063580Sonoace X8 Diagnostic Ultrasound SystemMedison Co., Ltd.2006129—
+5K061755MYLAB15/20 New Indications Ultrasound SystemEsaote Europe B.V.200628—
+5K061213Sonoace Pico Diagnostic Ultrasound SystemMedison Co., Ltd.2006114—
+5K060087Accuvix V7 Diagnostic Ultrasound SystemMedison Co., Ltd.20060—
+5K053154MYLAB15/20 3D/4D Ultrasound Imaging SystemPie Medical200529—
+5K053043Encompass Software PackageToshiba America Medical Systems, In.C20050—
+5K050503Single Use Aspiration Needle NA-201SX-4022Olympus Medical Systems Corporation2005285
+5K050380Xario Diagnostic Ultrasound System, Model Ssa-660AToshiba America Medical Systems, In.C200502
+5K043455SA8000 SE Diagnostic Ultrasound SystemMedison Co., Ltd.2004182—
+5K040926Ultrasound Scanner, Hudson Models 8000 and 9000Hudson Diagnostic Imaging, LLC20040—
+6K250863FUJIFILM Ultrasonic Endoscope EB-710USFujifilm Corporation20250—
+6K221340iNod Ultrasound Guided Biopsy Needle (UPN: M00502060), iNod Ultrasound Guidance Console…Boston Scientific Corporation20230—
+6K203128Evis Eus Endoscopic Ultrasound Center Olympus EU-ME2/Evis Eus Endoscopic Ultrasound…Olympus Medical Systems Corp.20201—
+6K200136Shear Wave Quantificational Ultrasound Diagnostic SystemWuxi Hisky Medical Technologies Co., Ltd.20202—
+6K192253SonicEye Dual-Array Ultrasound SystemSonivate Medical, Inc.20200—
+6K183525EVIS EUS Ultrasound Bronchofibervideoscope Olympus BF-UC190FOlympus Medical Systems Corp.201921
+6K191541Vave Personal Ultrasound SystemVave Health, Inc.20191—
+6K182825FUJIFILM Ultrasonic EndoscopeFujifilm Corporation20190—
+6K181574UscanEchoNous, Inc.20180—
+6K172931DUS-6000 Digital Ultrasonic Diagnostic Imaging SystemAdvanced Instrumentations, Inc.20170—
+6K173003U50 Diagnostic Ultrasound SystemEdan Instruments, Inc.20171—
+6K172380U2 Diagnostic Ultrasound SystemEdan Instruments, Inc.20170—
+6K163688Medisono Ultrasonic Diagnostic Imaging System, models P1, P3, and P10Medisono, LLC20170—
+6K161588Vscan ExtendGE Medical Systems Ultrasound & Primary Care Diagnostics, LLC2016258
+6K161300Acclarix AX8 Diagnostic Ultrasound SystemEdan Instruments, Inc.20169—
+6K160098Single Use Aspiration Needle NA-U401SXOlympus Medical Systems Corp.201612
+6K151315Expect Pulmonary Endobronchial Ultrasound Transbronchial Aspiration NeedleBoston Scientific Corporation20153—
+6K151895Expect Pulmonary Endobronchial Ultrasound Transbronchial Aspiration NeedleBoston Scientific Corporation20150—
+6K151339SONON Ultrasound Imaging System (Model: SONON 300C)Healcerion Co., Ltd.201533—
+6K151451Aplio 500/400/300 Diagnostic Ultrasound System V6.0Toshibamedical Systems Corporation2015342
+6K150999Acclarix Diagnostic Ultrasound SystemEdan Instruments, Inc.201512—
+6K142909Flexible 19G EBUS NeedleSpiration, Inc.20157—