510(k) Report

Devices descending from K101757

339 later devices reach Sonosite Nanomaxx Series Ultrasound System, Sonosite Maxx Series Ultrasound… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K132228Ugeo PT60A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.2013101—
+1K130173Sonosite Maxx Series Ultrasound SystemFUJIFILM Sonosite, Inc.2013521
+1K121646Acuson X150 Diagnostic Ultrasound System Sonovista X150 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. Ultrasound Gro20120—
+1K121699Acuson X300 Diagnostic Ultrasound System Sonovista X300 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.201298—
+1K113647DC-8/DC-8 Pro/DC-8 CV/DC-8 Exp/DC-8S Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.2011116—
+2K202160Sonosite PX Ultrasound System, Sonosite SII Ultrasound System, Sonosite iViz Ultrasound…FUJIFILM Sonosite, Inc.20200—
+2K173957ACUSON NX3 Diagnostic Ultrasound System; ACUSON NX3 ELITE Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.201882
+2K172059LinkQuest Diagnostic Ultrasound System model SQ860Linkquest, Inc.20170—
+2K160734SonoSite SII Ultrasound SystemFUJIFILM Sonosite, Inc.201612—
+2K152469ACUSON NX3 Elite / NX3 Diagnostic Ultrasound SystemSiemens Medical Solutions, Inc., Ultrasound Division2015332
+2K150050ACUSON P500 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.201528—
+2K142466UGEO PT60A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201499—
+2K142395SC2000 and ACUSON X300 Diagnostic Ultrasound SystemsSiemens Medical Solutions USA, Inc.20140—
+2K141846Acuson X700 Ultrasound System, Acuson X600 Ultrasound SystemSiemens Medical Solutions USA, Inc.201441—
+2K133505Sonoace R7 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201398—
+2K133454Sonosite Edge Ultrasound SystemFUJIFILM Sonosite, Inc.201350—
+2K123503DC-N3/DC-NS3 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.201277—
+2K123622AcusonSiemens Medical Solutions USA, Inc.20129613
+2K123185DC-8/DC-8 Pro/DC-8, CV/DC-8, Exp/DC-8S Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.201297—
+2K123001Acuson X700 Diagnstic Ultrasound SystemSiemens Medical Solutions USA, Inc.2012742
+2K121010M7/M7T Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.2012107—
+2K120699DC-T6 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.2012103—
+3K192835ACUSON NX3 Diagnostic Ultrasound System / ACUSON NX3 Elite Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.20197—
+3K191055HS40 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20199—
+3K182894HM70A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201910—
+3K180409HS40 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201834—
+3K180704SonoSite iViz Ultrasound SystemFUJIFILM Sonosite, Inc.20182—
+3K180039ACUSON P600 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.201825—
+3K172385Clarius Ultrasound SystemClarius Mobile Health Corp.201722—
+3K171437SonoSite X-Porte Ultrasound SystemFUJIFILM Sonosite, Inc.20177—
+3K163396ACUSON P500 Ultrasound SystemSiemens Medical Solutions USA, Inc.201727—
+3K162288SonoSite iViz Ultrasound SystemFUJIFILM Sonosite, Inc.20163—
+3K162045SonoSite SII Ultrasound System, SonoSite Edge II Ultrasound SystemFUJIFILM Sonosite, Inc.201611—
+3K161787ACUSON NX2 Diagnostic Ultrasound SystemsSiemens Medical Solutions USA, Inc.2016301
+3K160853Apogee 5500/Apogee 5300/ Apogee 5800 Digital Color Doppler Ultrasound Imaging SystemShantou Institute of Ultrasonic Instruments Co., Ltd. (Siui)20165—
+3K161119SonoSite iViz Ultrasound SystemFUJIFILM Sonosite, Inc.20164—
+3K160406FUJIFILM FC1 Ultrasound SystemFUJIFILM Sonosite, Inc.201612—
+3K153626SonoSite Edge II Ultrasound SystemFUJIFILM Sonosite, Inc.201642—
+3K152983FUJIFILM SonoSite iViz Ultrasound SystemFUJIFILM Sonosite, Inc.20155—
+3K152545DC-60/DC-60S/DC-60 EXP/DC-55 Diagnostic Ultrasound SystemsShenzhen Mindray Bio-Medical Electronics Co., Ltd.201513—
+3K152209FUJIFILM SonoSite X-Porte Ultrasound SystemFUJIFILM Sonosite, Inc.201545—
+3K151663RS80A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201596—
+3K150478A35 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201597—
+3K143264H60 V2.00 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201498—
+3K142876ACUSON S1000/ S2000/ S3000 Diagnostic Ultrasound SystemsSiemens Medical Solutions USA, Inc.2014581
+3K142017X-Porte Ultrasound SystemFUJIFILM Sonosite, Inc.201446—
+3K140030DC-N3/DC-N3S Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.20145—
+3K132779DC-N2/DC-N2S Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.201372—
+3K132804Acuson S1000 / S2000 / S3000Siemens Medical Solutions USA, Inc. Ultrasound Gro2013733
+3K132654Acuson SC2000 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. Ultrasound Gro201353—
+3K132341DC-8/ DC-8 Pro/ DC-8 CV/ DC-8 Exp/ DC-8S Diagnostic Ultrasound SystemsShenzhen Mindray Bio-Medical Electronics Co., Ltd.201396—
+3K131690M7/M7T Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.201392—
+3K132062Esie Apps SuiteSiemens Medical Solutions USA, Inc.20133—
+3K130833DP-20 Digital Ultrasonic Diagnostic Imaging System; DP-30 Digital Ultrasonic Diagnostic…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20130—
+3K130754Acuson SC2000 Diagnostic Ultrasound SystemSiemens Medi Cal Solutions, Inc.201354—
+4K260595Sonosite iLOOK Ultrasound SystemFUJIFILM Sonosite, Inc.20260—
+4K250955XC11 ICE System, USAYorlabs, Inc.20250—
+4K233597Sonosite LX Ultrasound SystemFUJIFILM Sonosite, Inc.20233—
+4K223920Vinno G50, Vinno G55, Vinno M50, Vinno E30, Vinno X5, Vinno X6, Vinno X7, Vinno M55…Vinno Technology (Suzhou) Co.,Ltd20230—
+4K220983ImSonic TR-1 Ultrasonic Pulsed Doppler Imaging SystemImsonic Medical China, Inc.20220—
+4K213487ACUSON P500 Ultrasound SystemSiemens Medical Solutions USA, Inc.20221—
+4K213763Sonosite PX Ultrasound SystemFUJIFILM Sonosite, Inc.20214—
+4K210318Apogee 6500,Apogee 6300,Apogee 6200 Digital Color Doppler Ultrasound Imaging SystemShantou Institute of Ultrasonic Instruments Co., Ltd. (Siui)20210—
+4K202683ACUSON Sequoia Diagnostic Ultrasound System, ACUSON SC2000 Diagnostic Ultrasound System…Siemens Medical Solutions USA, Inc.20206—
+4K201130ACUSON Juniper Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.2020144
+4K200964Sonosite PX Ultrasound SystemFUJIFILM Sonosite, Inc.20206—
+4K200339HS40 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20208—
+4K191235Leltek Ultrasound Imaging SystemLeltek, Inc.20209—
+4K191922ACUSON P200 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.201923—
+4K183235SonoSite SII Ultrasound SystemFUJIFILM Sonosite, Inc.20191—
+4K182636DC-60/DC-60S/DC-60 Exp/DC-55 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.20190—
+4K182632HS30 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20191—
+4K181336HS50 / HS60 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201831—
+4K180799Clarius Ultrasound ScannerClarius Mobile Health Corp.201811—
+4K163712Clover 50/Clover60/Clover70 Diagnostic Ultrasound SystemShenzhen Wisonic Medical Technology Co., Ltd.20181—
+4K173369DC-30/DC-32/DC-28/DC-26/DC-25 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Meidcal Electronics Co., Ltd.20172—
+4K173000Apogee 2100 Digital Color Doppler Ultrasound Imaging System Apogee 2300 Digital Color…Shantou Institute of Ultrasonic Instruments Co., Ltd. (Siui)20173—
+4K173265UltraVision 2 Diagnostic Ultrasound SystemWinprobe Corporation20172—
+4K172970M7/M7T/M7 Premium/M7 Expert/M7 Super Diagnostic UltrasoundShenzhen Mindray Bio-Medical Electronics Co., Ltd.20170—
+4K171579M6/M6T/M6 EXP/M6S/M6 PRO/M5 EXP/M55/M58 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.20170—
+4K172374ACUSON NX2 Diagnostic Ultrasound System, ACUSON NX2 Elite Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.201712
+4K163690DC-70/DC-70T /DC-70 Pro/DC-70 Exp/DC-75/DC-78/DC-70S Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.20179—
+4K170493HS50 / HS60 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201737—
+4K170277DC-8/DC-8 PRO/DC-8 CV/DC-8 EXP/DC-8S Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.201720—
+4K163691HS70A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201758—
+4K162845DC-40/DC-35/DC-45/DC-40S/DC-40 Pro Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.20161—
+4K163138Clarius Ultrasound SystemClarius Mobile Health Corp.201628—
+4K153539RS80A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201659—
+4K162094RS80A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201664—
+4K1619555D ViewerSamsung Medison Co., Ltd.20163—
+4K161525TE7 Diagnostic Ultrasound, TE5 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.201612—
+4K153424E-CUBE i7Alpinion Medical Systems Co., Ltd.201614—
+4K153529WS80A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.2016891
+4K153408HM70A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201565—
+4K152962HS70A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201590—
+4K152369ACUSON S1000, S2000, S3000 Diagnostic Ultrasuond SystemSiemens Medical Solutions USA, Inc. Ultrasound Group201554—
+4K150861QBit Series Diagnostic Ultrasound SystemChison Medical Imaging Co., Ltd.20159—
+4K150080DC-8/DC-8 Pro/DC-8 CV/DC-8 Exp/DC-8SShenzhen Mindray Bio-Medical Electronics Co., Ltd.201579—
+4K150999Acclarix Diagnostic Ultrasound SystemEdan Instruments, Inc.201512—
+4K150204DC-70/DC-70T/DC-70 PRO/DC-70 EXP Diagnostic Ultrasound SystemsShenzhen Mindray Bio-Medical Electronics Co., Ltd.201571—