510(k) Report

Devices descending from K042055

827 later devices reach Cypress Ultrasound System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+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—
+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—
+6K142368Noblus Diagnostic Ultrasound ScannerHitachi Aloka Medical, Ltd.2015581
+6K143089WS80A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201499—
+6K142876ACUSON S1000/ S2000/ S3000 Diagnostic Ultrasound SystemsSiemens Medical Solutions USA, Inc.2014581
+6K142628Acuson SC2000 Diagnostic Ultrasound SystemSiemens Medi Cal Solutions, Inc.201450—
+6K142008Mylabseven, MylabalphaEsaote, S.p.A.2014193
+6K142395SC2000 and ACUSON X300 Diagnostic Ultrasound SystemsSiemens Medical Solutions USA, Inc.20140—
+6K141554Esie Apps SuiteSiemens Medical Solutions USA, Inc.20142—
+6K141369Visiq Diagnostic Ultra Sound SystemPhilips Ultrasound, Inc.20140—
+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—
+6K132231Mylabseven, MylabalphaEsaote, S.p.A.201322—
+6K133329Ugeo WS80A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.2013102—
+6K132274AixplorerSupersonic Imagine2013312—
+6K132304Epiq Diagnostic Ultrasound SystemPhilips Ultrasound, Inc.201321136
+6K132062Esie Apps SuiteSiemens Medical Solutions USA, Inc.20133—
+6K130499IU22 Diagnostic Ultrasound SystemPhilips Ultrasound, Inc.20132122
+6K130754Acuson SC2000 Diagnostic Ultrasound SystemSiemens Medi Cal Solutions, Inc.201354—
+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
+6K103677M7/M7T Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.2011123—
+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—
+7K243937Accuro 3SRivanna Medical, Inc.20252—
+7K242893VERAFEYE System VERAFEYE Imaging Catheter & VERAFEYE Imaging SystemLuma Vision Limited20252—
+7K241554Portable Digital Color Doppler Ultrasound System (SCN201D, SCN201L)Telefield Medical Imaging (Shenzhen) Limited20240—
+7K233613ACUSON SC2000 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.20240—
+7K223771Lumify Diagnostic Ultrasound SystemPhilips Ultrasound202322
+7K221340iNod Ultrasound Guided Biopsy Needle (UPN: M00502060), iNod Ultrasound Guidance Console…Boston Scientific Corporation20230—
+7K221190ACUSON Juniper Diagnostic Ultrasound System and ACUSON Juniper Select Diagnostic…Siemens Medical Solutions USA, Inc.20224—
+7K210432LELTEK Ultrasound Imaging System (Model: LU700 Series)Leltek, Inc.20218—
+7K210318Apogee 6500,Apogee 6300,Apogee 6200 Digital Color Doppler Ultrasound Imaging SystemShantou Institute of Ultrasonic Instruments Co., Ltd. (Siui)20210—
+7K211859ACUSON Sequoia Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.202171
+7K210743ACUSON Redwood Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.2021153
+7K202035Vscan AirGE Medical Systems Ultrasound and Primary Care Diagnostics20203—
+7K203128Evis Eus Endoscopic Ultrasound Center Olympus EU-ME2/Evis Eus Endoscopic Ultrasound…Olympus Medical Systems Corp.20201—
+7K200708Vivid iqGe Medical Systems Ultrasound And20203—
+7K201389Resoundant Acoustic Driver SystemResoundant, Inc.20201—
+7K193518KosmosEchoNous, Inc.20201—
+7K192107Clarius Ultrasound ScannerClarius Mobile Health Corp.201910—
+7K191798Versana ActiveGE Medical Systems Ultrasound and Primary Care Diagnostics20191—
+7K191792Versana BalanceGE Medical Systems Ultrasound and Primary Care Diagnostics20193—
+7K181934Vivid T8, Vivid T9GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC20183—
+7K181617E-CUBE 8Alpinion Medical Systems Co., Ltd.20180—
+7K180572AIXPLORER MACH Ultrasound Diagnostic Systems Aixplorer Mach 30, Aixplorer Mach 20…Supersonic Imagine201816—
+7K173513WS80A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.2018321
+7K173204RS85 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201839—
+7K173957ACUSON NX3 Diagnostic Ultrasound System; ACUSON NX3 ELITE Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.201882
+7K1732916440 Ultrasound SystemEsaote, S.p.A.20188—
+7K171207FUJIFILM Ultrasonic Processor SP-900 and FUJIFILM Ultrasonic Probe PB2020-MFujifilm Medical Systems U.S.A, Inc.20181—
+7K173768Tempus Pro Patient MonitorRemote Diagnostic Technologies, Ltd.20181—
+7K172732E-CUBE 8Alpinion Medical Systems Co., Ltd.201711—
+7K173000Apogee 2100 Digital Color Doppler Ultrasound Imaging System Apogee 2300 Digital Color…Shantou Institute of Ultrasonic Instruments Co., Ltd. (Siui)20173—
+7K173265UltraVision 2 Diagnostic Ultrasound SystemWinprobe Corporation20172—
+7K172607Philips EPIQ 5 Diagnostic Ultrasound System, EPIQ 7 Diagnostic Ultrasound System…Philips Health Care20172831
+7K171048RS80A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201750—
+7K172374ACUSON NX2 Diagnostic Ultrasound System, ACUSON NX2 Elite Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.201712
+7K171105AIXPLORER® & AIXPLORER® Ultimate Ultrasound SystemsSupersonic Imagine201719—
+7K170374SonoBook Series Diagnostic Ultrasound SystemChison Medical Imaging Co., Ltd.20175—
+7K163119NaviSuite SSI EditionMedcom GmbH20171—
+7K163690DC-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—
+7K163443Interson USB Ultrasound SystemInterson Corporation20173—
+7K170277DC-8/DC-8 PRO/DC-8 CV/DC-8 EXP/DC-8S Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.201720—
+7K162055Acclarix LX8 Diagnostic Ultrasound SystemEdan Instruments, Inc.20178—
+7K162902ARIETTA Prologue Diagnostic Ultrasound system and TransducersHitachi, Ltd.20160—
+7K162065Ultrasound System SONIMAGE HS1Konica Minolta, Inc.201622
+7K160559NOBLUS™ Ultrasound Diagnostic SystemHitachi Medical Corporation201601
+7K153539RS80A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201659—
+7K162549Lumify Ultrasound SystemPhilips Health Care2016436
+7K162172EBit Series Diagnostic Ultrasound SystemChison Medical Imaging Co., Ltd.20161—
+7K162221ACUSON SC2000 Diagnostic Ultrasound SystemSiemens Medical Solutions Inc. Ultrasound Group2016481
+7K162267Resona 7/Resona 7CV/Resona 7EXP/Resona 7S/Resona 7OB Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.201653—
+7K161168MyLabSix Ultrasound SystemEsaote Europe B.V.20161—
+7K162094RS80A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201664—
+7K152126Ust-5550-R; Ust-5536-R; L43KHitachi Aloka Medical America, Inc.201601
+7K1619555D ViewerSamsung Medison Co., Ltd.20163—
+7K1613596400 Ultrasound System,7400 Ultrasound System, 7410 Ultrasound SystemEsaote, S.p.A.201645