510(k) Report

Devices descending from K070792

202 later devices reach Qlab Quantification through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K150533Terason uSmart3200T Ultrasound SystemTeratech Corp.20152—
+1K150148Terason uSmart3300 Ultrasound SystemTeratech Corp.20150—
+1K130779Lvivo EF SystemDiacardio, Ltd.201324—
+1K132165Qlab Quantification SoftwarePhilips Ultrasound, Inc.2013911
+1K121223Qlab with FHN and VPQ Plug-inPhilips Ultrasound, Inc.201298—
+1K120525Qlab Quantification SoftwarePhilips Healthcare Group201292—
+2K193510Terason uSmart3200T Ultrasound SystemTeratech Corporation20201—
+2K180995Vscan ExtendGE Medical Systems Ultrasound and Primary Care Diagnostics2018107
+2K173780EchoMD Automated Ejection Fraction SoftwareBay Labs, Inc.201810—
+2K171048RS80A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201750—
+2K172162ACUSON S3000 S2000 S1000 Diagnostic Ultrasound SystemsSiemens Healthcare201743—
+2K171314QLAB Advanced Quantification SoftwarePhilips Health Care201745—
+2K170069AmCAD-UVAmcad Biomed Corporation20170—
+2K162094RS80A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201664—
+2K161382LVivo Software ApplicationDiacardio, Ltd.20160—
+2K143176UltraLinqUltralinq Healthcare Solutions, Inc.20150—
+2K121781Echonavigator Release 1Philips Medical Systems Nederland B.V.201232—
+3K220956Libby Echo:PrioDyad Medical, Inc.20221—
+3K210791Us2.v1Eko.Ai Pte Ltd. D/B/A Us2.Ai20213—
+3K210743ACUSON Redwood Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.2021153
+3K202035Vscan AirGE Medical Systems Ultrasound and Primary Care Diagnostics20203—
+3K202683ACUSON Sequoia Diagnostic Ultrasound System, ACUSON SC2000 Diagnostic Ultrasound System…Siemens Medical Solutions USA, Inc.20206—
+3K200621Caption Interpretation Automated Ejection Fraction SoftwareCaption Health202031
+3K201633Terason uSmart 3200T Plus Ultrasound SystemTeratech Corporation20200—
+3K201462ACUSON Sequoia Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.2020241
+3K200707ACUSON Sequoia Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.202025—
+3K200713EchoNavigatorPhilips Medical Systems Nederland B.V.20202—
+3K193518KosmosEchoNous, Inc.20201—
+3K193257ACUSON Sequoia Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.2020261
+3K183575ACUSON S3000, S2000 Diagnostic Ultrasound SystemSiemens Healthineers201926—
+3K181934Vivid T8, Vivid T9GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC20183—
+3K181264QLAB Advanced Quantification SoftwarePhilips Ultrasound, Inc.201844—
+3K180799Clarius Ultrasound ScannerClarius Mobile Health Corp.201811—
+3K173713HS70A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201891
+3K173513WS80A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.2018321
+3K180067ACUSON X800 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.201828—
+3K173204RS85 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201839—
+3K172607Philips EPIQ 5 Diagnostic Ultrasound System, EPIQ 7 Diagnostic Ultrasound System…Philips Health Care20172831
+3K171070WS80A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201742—
+3K170493HS50 / HS60 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201737—
+3K163691HS70A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201758—
+4K260748ES-SeriesE-Scopics20260—
+4K252105Ligence HeartLigence Uab20250—
+4K250120GECHONarnar, LLC20250—
+4K250670EchoConfidence (USA)Mycardium AI Limited20250—
+4K243299ACUSON Redwood Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.20240—
+4K241430EchoMeasureIcardio.Ai20240—
+4K234153EdgeLife Handheld Wireless Ultrasound System (E8200); EdgeLife Handheld Wireless…Edgelife Technologies, LLC20240—
+4K233676Us2.v2Eko.Ai Pte Ltd. D/B/A Us2.Ai20240—
+4K231301Vscan AirGE Medical Systems Ultrasound and Primary Care Diagnostics20231—
+4K221190ACUSON Juniper Diagnostic Ultrasound System and ACUSON Juniper Select Diagnostic…Siemens Medical Solutions USA, Inc.20224—
+4K221500ACUSON Sequoia Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.20226—
+4K221270EchoNavigator R4.0Philips Medical Systems Nederland B.V.20221—
+4K212851EchoSK and EchoSGyn modules for EchoS Family devicesEcholight S.P.A20220—
+4K213487ACUSON P500 Ultrasound SystemSiemens Medical Solutions USA, Inc.20221—
+4K210747Caption Interpretation Automated Ejection Fraction SoftwareCaption Health20222—
+4K211726Acuson SC2000 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.20214—
+4K212100KosmosEchoNous, Inc.202101
+4K211859ACUSON Sequoia Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.202171
+4K200851Vivid T8, Vivid T9GE Medical Systems Ultrasound and Primary Care Diagnostics20202—
+4K200699HS70A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20200—
+4K191647QLAB Advanced Quantification SoftwarePhilips Health Care201941—
+4K192107Clarius Ultrasound ScannerClarius Mobile Health Corp.201910—
+4K191922ACUSON P200 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.201923—
+4K190913QLAB Advanced Quantification Software 13Philips Health Care20191—
+4K182932RS85 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201924—
+4K182894HM70A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201910—
+4K182595HERA W10 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201826—
+4K181336HS50 / HS60 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201831—
+4K181617E-CUBE 8Alpinion Medical Systems Co., Ltd.20180—
+4K181277E-CUBE 12Alpinion Medical Systems Co., Ltd.20187—
+4K181485EPIQ , EPIQ 5, EPIQ 7, Affiniti 30, Affiniti 50 and Affiniti 70 Diagnostic Ultrasound…Philips Ultrasound, Inc.20182724
+4K1808835D ViewerSamsung Medison Co., Ltd.20180—
+4K172732E-CUBE 8Alpinion Medical Systems Co., Ltd.201711—
+4K172129HS40 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201735—
+5K262548EPIQ Inspira Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound…Philips Ultrasound, LLC20260—
+5K253614EchoNavigator R5.0Philips Medical Systems Nederland B.V.20260—
+5K253593Clarius Ejection Fraction AIClarius Mobile Health Corp.20260—
+5K250087Vscan AirGE Medical Systems Ultrasound and Primary Care Diagnostics20250—
+5K242893VERAFEYE System VERAFEYE Imaging Catheter & VERAFEYE Imaging SystemLuma Vision Limited20252—
+5K233613ACUSON SC2000 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.20240—
+5K233610ACUSON P500 Ultrasound System; ACUSON P500 ICE Ultrasound SystemSiemens Medical Solutions USA, Inc.20240—
+5K232331InVision Precision LVEF (LVEF)InVision Medical Technology Corporation20240—
+5K230207ACUSON Juniper Diagnostic Ultrasound System, ACUSON Juniper Select Diagnostic Ultrasound…Siemens Medical Solutions USA, Inc.20233—
+5K223735ACUSON Sequoia Diagnostic Ultrasound System, ACUSON Sequoia Select Diagnostic Ultrasound…Siemens Medical Solutions USA, Inc.20235—
+5K221147Vivid T8, Vivid T9GE Medical Systems Ultrasound and Primary Care Diagnostics20221—
+5K211665SONON Ultrasound Imaging System, Model: SONON300CHealcerion Co., Ltd.20220—
+5K212400SONON Ultrasound Imaging System, Model: SONON 500LHealcerion Co., Ltd.20220—
+5K220490ImaCor Zura Handheld ZHH-010Imacor, Inc.202202
+5K211746Pocket Ultrasound SystemGuangdong Youkey Medical Co., Ltd.20221—
+5K212012Follicle ClarityCycle Clarity20221—
+5K213436Clarius Ultrasound ScannerClarius Mobile Health Corp.20212—
+5K211161Critical Care Suite with Endotracheal Tube Positing AI algorithmGe Medical Systems, LLC20211—
+5K211232Apache Ultrasound SystemAco Healthcare Co., Ltd.20210—
+5K202074Apache Ultrasound System (Model C62)Compal Electronics, Inc.20200—
+5K2013523D Auto LAAPhilips Health Care20200—
+5K200449X-Cube 90Alpinion Medical Systems Co., Ltd.20204—
+5K200450X-Cube 70Alpinion Medical Systems Co., Ltd.20204—
+5K200356Medo AriaMedo.Ai20203—
+5K200974QLAB Advanced Quantification SoftwarePhilips Health Care202012—