510(k) Report

Devices descending from K043016

927 later devices reach Sonoline Orchid Diagnostic Ultrasound System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K091970Aixplorer Ultrasound SystemSupersonic Imagine2009528—
+5K091009MY LABS25 Gold/MYLAB30 Gold Cardiovascular Model 7340, MY LAB70/MY LAB70XVISION/MYLAB60…Esaote, S.p.A.200951—
+5K081148Siemens Acuson 2000 Ultrasound System with Abvs TransducerSiemens Medical Solutions USA, Inc., Ultrasound DI20083253
+5K083095Sonixtouch Ultrasound SystemUltrasonix Medical Corporation2008582—
+5K082326Zonare Ultra Ultrasound SystemZonare Medical Systems, Inc.2008133—
+6K250955XC11 ICE System, USAYorlabs, Inc.20250—
+6K250026Shear Wave Quantificational Ultrasound Diagnostic System…Wuxi Hisky Medical Technologies Co., Ltd.20250—
+6K243880Shear Wave Quantificational Ultrasound Diagnostic System (Mini900, Mini990, Mini800…Wuxi Hisky Medical Technologies Co., Ltd.20250—
+6K232661Myocardial Strain Software ApplicationCircle Cardiovascular Imaging20231—
+6K220956Libby Echo:PrioDyad Medical, Inc.20221—
+6K213487ACUSON P500 Ultrasound SystemSiemens Medical Solutions USA, Inc.20221—
+6K210318Apogee 6500,Apogee 6300,Apogee 6200 Digital Color Doppler Ultrasound Imaging SystemShantou Institute of Ultrasonic Instruments Co., Ltd. (Siui)20210—
+6K210791Us2.v1Eko.Ai Pte Ltd. D/B/A Us2.Ai20213—
+6K202035Vscan AirGE Medical Systems Ultrasound and Primary Care Diagnostics20203—
+6K202683ACUSON Sequoia Diagnostic Ultrasound System, ACUSON SC2000 Diagnostic Ultrasound System…Siemens Medical Solutions USA, Inc.20206—
+6K200621Caption Interpretation Automated Ejection Fraction SoftwareCaption Health202031
+6K200232LVivo Software ApplicationDia Imaging Analysis, Ltd.202019—
+6K200979DP-50/DP-50T/DP-50Expert/DP-50S/DP-50Pro Digital Ultrasonic Diagnostic Imaging SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.20200—
+6K201130ACUSON Juniper Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.2020144
+6K200251Z5/Z50/Z50T/Z50S/Z50 Pro Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.20200—
+6K193518KosmosEchoNous, Inc.20201—
+6K192372ASCEND Image ViewerAscend Hit20200—
+6K190314Advanced Intelligent Volumetric Ultrasound System, Model AiVUS 1000Mednovel Technology, Ltd.20190—
+6K191922ACUSON P200 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.201923—
+6K183041Full Digital Colour Doppler Ultrasonic Diagnostic SystemWuhan Zoncare Bio-medical Electronics Co., Ltd.20190—
+6K183575ACUSON S3000, S2000 Diagnostic Ultrasound SystemSiemens Healthineers201926—
+6K182603Z6 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.20181—
+6K181934Vivid T8, Vivid T9GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC20183—
+6K180408U60 Diagnostic Ultrasound SystemEdan Instruments, Inc.20180—
+6K173000Apogee 2100 Digital Color Doppler Ultrasound Imaging System Apogee 2300 Digital Color…Shantou Institute of Ultrasonic Instruments Co., Ltd. (Siui)20173—
+6K173265UltraVision 2 Diagnostic Ultrasound SystemWinprobe Corporation20172—
+6K172059LinkQuest Diagnostic Ultrasound System model SQ860Linkquest, Inc.20170—
+6K172374ACUSON NX2 Diagnostic Ultrasound System, ACUSON NX2 Elite Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.201712
+6K170078Medisono Color Doppler Ultrasound System, models P11 Portable, P11 EXPERT Portable, P12…Medisono, LLC20170—
+6K1630826200 Ultrasound System and 6250 Ultrasound SystemEsaote, S.p.A.201792
+6K162055Acclarix LX8 Diagnostic Ultrasound SystemEdan Instruments, Inc.20178—
+6K163120EPIQ 5 Diagnostic Ultrasound System; EPIQ 7 Diagnostic Ultrasound System; Affiniti 50…Philips Ultrasound, Inc.20175828
+6K161999AixplorerSupersonic Imagine201620—
+6K1532776200 Ultrasound System and 6250 Ultrasound SystemEsaote, S.p.A.201612—
+6K160790Acclarix LX8 Diagnostic Ultrasound SystemEdan Instruments, Inc.20169—
+6K153421HI Vision Ascendus, HV Ascendus, AscendusHitachi Aloka Medical America, Inc.20160—
+6K152369ACUSON S1000, S2000, S3000 Diagnostic Ultrasuond SystemSiemens Medical Solutions USA, Inc. Ultrasound Group201554—
+6K151663RS80A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201596—
+6K150861QBit Series Diagnostic Ultrasound SystemChison Medical Imaging Co., Ltd.20159—
+6K151709Hi-Light Diagnostic Ultrasound SystemsQingdao Hisense Medical Equipment Co., Ltd.20150—
+6K150002iNSIGHT Color Doppler Ultrasound SystemSaset (Chengdu), Inc.20150—
+6K150080DC-8/DC-8 Pro/DC-8 CV/DC-8 Exp/DC-8SShenzhen Mindray Bio-Medical Electronics Co., Ltd.201579—
+6K150045S30/S40 Digital Color Doppler Ultraound SystemSonoscape Company Limited201517—
+6K150204DC-70/DC-70T/DC-70 PRO/DC-70 EXP Diagnostic Ultrasound SystemsShenzhen Mindray Bio-Medical Electronics Co., Ltd.201571—
+6K150580UltraVision 2 Diagnostic Ultrasound SystemWinprobe Corporation20150—
+6K150122Tomtec-Arena TTA2Tomtec Imaging Systems GmbH2015561
+6K142714S8 Exp/S9 Pro Portable Digital Color Doppler Ultrasound SystemSonoscape Company Limited20154—
+6K142815S22 Digital Color Doppler Ultrasound SystemSonoscape Company Limited20152—
+6K142368Noblus Diagnostic Ultrasound ScannerHitachi Aloka Medical, Ltd.2015581
+6K142710S9 Portable Digital Color Doppler Ultrasound SystemSonoscape Company Limited201519—
+6K143089WS80A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201499—
+6K142628Acuson SC2000 Diagnostic Ultrasound SystemSiemens Medi Cal Solutions, Inc.201450—
+6K142008Mylabseven, MylabalphaEsaote, S.p.A.2014193
+6K141554Esie Apps SuiteSiemens Medical Solutions USA, Inc.20142—
+6K141010M9 Diagnostic Ultrasound System, M9T Diagnostic Ultrasound System, M9CV Diagnostic…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.201483—
+6K140959Acuson S1000, S2000, S3000 Diagnostic Ultrasound SystemsSiemens Medical Solutions USA, Inc.201460—
+6K140677MylabssognoEsaote, S.p.A.20140—
+6K140030DC-N3/DC-N3S Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.20145—
+6K132231Mylabseven, MylabalphaEsaote, S.p.A.201322—
+6K133329Ugeo WS80A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.2013102—
+6K132779DC-N2/DC-N2S Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.201372—
+6K132274AixplorerSupersonic Imagine2013312—
+6K132304Epiq Diagnostic Ultrasound SystemPhilips Ultrasound, Inc.201321136
+6K131158CorviewMarrek, Inc.20130—
+6K132165Qlab Quantification SoftwarePhilips Ultrasound, Inc.2013911
+6K130833DP-20 Digital Ultrasonic Diagnostic Imaging System; DP-30 Digital Ultrasonic Diagnostic…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20130—
+6K130499IU22 Diagnostic Ultrasound SystemPhilips Ultrasound, Inc.20132122
+6K130058Endoscopic Ultrasound Center EU-Y0008Olympus Medical Systems Corp.20134—
+6K123503DC-N3/DC-NS3 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.201277—
+6K121564Endoscopic Ultrasound Center EU-Y0006Olympus Medical Systems Corp.20126—
+6K111142Echosoft (TM)Echometrix, LLC20120—
+6K112255AixplorerSupersonic Imagine2012525—
+6K121384MylabsognoEsaote, S.p.A.201211
+6K121010M7/M7T Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.2012107—
+6K120699DC-T6 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.2012103—
+6K120703Zonare ZS3 Diagnostic Unltrasound SystemZonare Medical Systems, Inc.201224—
+6K112726Sonix Ultrasound ScannerUltrasonix Medical Corporation20110—
+6K110673HI Vision Ascendus Diagnostic Ultrasound ScannerHitachi Medical Systems America, Inc.201185—
+6K111302Mylabseven, MylabalphaEsaote, S.p.A.201124—
+6K110414Qlab 8.1 Quantification SoftwarePhilips Ultrasound, Inc.20110—
+6K110688MylabgoldEsaote2011251
+6K1031526250 Ultrasound SytemsEsaote, S.p.A.201135—
+6K102997Sonixtablet Ultrasound ScannerUltrasonix Medical Corporation201077—
+6K102901HI Vision Avius Diagnostic Ultrasound ScannerHitachi Medical Systems America, Inc.2010601
+6K101091Z.One Ultra Ultrasound SystemZonare Medical Systems, Inc.2010132—
+6K100989Zura Tee System with Claritee ProbeImacor, Inc.201011
+6K092271GE Logiq E9 BT2010 Diagnostic Ultrasound System, Model 5205000-3, 5205000-4GE Healthcare20095691
+6K083421MR-Touch OptionGe Medical Systems, LLC20094—
+7K260748ES-SeriesE-Scopics20260—
+7K252105Ligence HeartLigence Uab20250—
+7K250670EchoConfidence (USA)Mycardium AI Limited20250—
+7K243178Digital Color Doppler Ultrasound Imaging System (Apogee C1); Digital Color Doppler…Shantou Institute of Ultrasonic Instruments Co., Ltd.20250—
+7K243132Digital Color Doppler Ultrasound Imaging System (Readius L15); Digital Color Doppler…Shantou Institute of Ultrasonic Instruments Co., Ltd.20240—
+7K241554Portable Digital Color Doppler Ultrasound System (SCN201D, SCN201L)Telefield Medical Imaging (Shenzhen) Limited20240—
+7K242781cvi42 Software ApplicationCircle Cardiovascular Imaging, Inc.20240—