510(k) Report

Devices descending from K001592

234 later devices reach Echocom, Imagecom, Dokucom through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+7K220940EchoPAC Software Only, EchoPAC Plug-inGE Medical Systems Ultrasound and Primary Care Diagnostics20222—
+7K210743ACUSON Redwood Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.2021153
+7K202683ACUSON Sequoia Diagnostic Ultrasound System, ACUSON SC2000 Diagnostic Ultrasound System…Siemens Medical Solutions USA, Inc.20206—
+7K200708Vivid iqGe Medical Systems Ultrasound And20203—
+7K200851Vivid T8, Vivid T9GE Medical Systems Ultrasound and Primary Care Diagnostics20202—
+7K200497Vivid S60N, Vivid S70NGE Medical Systems Ultrasound and Primary Care Diagnostics202042
+7K201462ACUSON Sequoia Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.2020241
+7K200195NES Reprocessed Visions PV .014P RX Digital IVUS CatheterNortheast Scientific, Inc.20201—
+7K200707ACUSON Sequoia Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.202025—
+7K193183ACIST HDi System, ACIST Kodama Intravascular Ultrasound CatheterAcist Medical Systems, Inc.20200Class I
+7K193257ACUSON Sequoia Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.2020261
+7K191798Versana ActiveGE Medical Systems Ultrasound and Primary Care Diagnostics20191—
+7K191792Versana BalanceGE Medical Systems Ultrasound and Primary Care Diagnostics20193—
+7K183575ACUSON S3000, S2000 Diagnostic Ultrasound SystemSiemens Healthineers201926—
+7K181685Vivid E80, Vivid E90, Vivid E95GE Medical Systems Ultrasound and Primary Care Diagnostics201813—
+7K181264QLAB Advanced Quantification SoftwarePhilips Ultrasound, Inc.201844—
+7K180799Clarius Ultrasound ScannerClarius Mobile Health Corp.201811—
+7K180067ACUSON X800 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.201828—
+7K133323Volcano Ifr ModalityVolcano Corporation201418—
+7K133142Volcano Lomap,Volcano Lomap Option Kit for Mobile System,Volcano Lomap Option for…Volcano Corporation20130—
+7K132659Volcano Preview Forward-Looking Ivus SystemVolcano Corporation20130—
+7K122826Preview Forward-Looking Ivus Catheter and Laptop System; Preview Catheter Model 87000…Volcano Corporation20131—
+8K260748ES-SeriesE-Scopics20260—
+8K260217AI Platform 2.2 (AIP002)Exo Imaging20260—
+8K251342EchoPAC Software Only / EchoPAC Plug-inGE Medical Systems Ultrasound and Primary Care Diagnostics20251—
+8K250120GECHONarnar, LLC20250—
+8K243684BrightHeart View ClassifierBrightheart20251—
+8K243862LVivo Software ApplicationDia Imaging Analysis, Ltd.20250—
+8K243235LVivo Software ApplicationDia Imaging Analysis, Ltd.20250—
+8K240645Sonix HealthOntact Health Co., Ltd.20240—
+8K243299ACUSON Redwood Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.20240—
+8K221190ACUSON Juniper Diagnostic Ultrasound System and ACUSON Juniper Select Diagnostic…Siemens Medical Solutions USA, Inc.20224—
+8K221148Vivid iqGE Medical Systems Ultrasound & Primary Care Diagnostics, LLC20222—
+8K221147Vivid T8, Vivid T9GE Medical Systems Ultrasound and Primary Care Diagnostics20221—
+8K221500ACUSON Sequoia Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.20226—
+8K220446Versana BalanceGE Medical Systems Ultrasound and Primary Care Diagnostics20221—
+8K212851EchoSK and EchoSGyn modules for EchoS Family devicesEcholight S.P.A20220—
+8K213487ACUSON P500 Ultrasound SystemSiemens Medical Solutions USA, Inc.20221—
+8K211726Acuson SC2000 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.20214—
+8K211859ACUSON Sequoia Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.202171
+8K211216Vivid S60N / Vivid S70NGE Medical Systems Ultrasound and Primary Care Diagnostics202132
+8K201768Voluson E10GE Healthcare20204—
+8K200743Vivid E80/ Vivid E90/ Vivid E95Ge Medical Systems Ultrasound And20207—
+8K200998Versana ActiveGE Medical Systems Ultrasound and Primary Care Diagnostics20200—
+8K191647QLAB Advanced Quantification SoftwarePhilips Health Care201941—
+8K192107Clarius Ultrasound ScannerClarius Mobile Health Corp.201910—
+8K191922ACUSON P200 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.201923—
+8K190913QLAB Advanced Quantification Software 13Philips Health Care20191—
+8K183320Ilumien Optis, Optis Integrated, Optis MobileSt. Jude Medical (Now Abbott Medical)20192—
+8K183099QUANTIEN Measurement SystemSt. Jude Medical (Now Abbott Medical)20193—
+8K173860s5 Intravascular Ultrasound Imaging and Pressure Systems, s5i Intravascular Ultrasound…Volcano Corporation20184—
+8K153369SW v3.5 Install Kit, CORE Mobile, SW v3.5 Install Kit, CORE, SW v3.5 Install Kit, s5izVolcano Corporation20152—
+8K150441Volcano iFR Modality, iFR Scout featureVolcano Corporation20159—
+8K143122Volcano iFR Harvest Software (Offline)Volcano Corporation20150—
+9K262548EPIQ Inspira Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound…Philips Ultrasound, LLC20260—
+9K261623EchoPAC Software Only / EchoPAC Plug-in (v211)GE Medical Systems Ultrasound and Primary Care Diagnostics20260—
+9K252238CoroFlow Cardiovascular SystemCoroventis Research AB20250—
+9K250913TINGSN FINDERS 2 Color Doppler Diagnostic Ultrasound SystemJiangsu Tingsn Technology Co., Ltd.20250—
+9K251456BrightHeart View ClassifierBrightheart20250—
+9K242893VERAFEYE System VERAFEYE Imaging Catheter & VERAFEYE Imaging SystemLuma Vision Limited20252—
+9K243628Vivid T9/Vivid T8GE Medical Systems Ultrasound and Primary Care Diagnostics20250—
+9K243620Vivid iqGE Medical Systems Ultrasound and Primary Care Diagnostics20250—
+9K233613ACUSON SC2000 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.20240—
+9K233610ACUSON P500 Ultrasound System; ACUSON P500 ICE Ultrasound SystemSiemens Medical Solutions USA, Inc.20240—
+9K232386ILUMIEN™ OPTIS™ System, OPTIS™ Integrated System, OPTIS™ Mobile System, with AptiVue™…Abbott Medical20230—
+9K223407Versana EssentialGE Medical Systems Ultrasound and Primary Care Diagnostics20230—
+9K230207ACUSON Juniper Diagnostic Ultrasound System, ACUSON Juniper Select Diagnostic Ultrasound…Siemens Medical Solutions USA, Inc.20233—
+9K223735ACUSON Sequoia Diagnostic Ultrasound System, ACUSON Sequoia Select Diagnostic Ultrasound…Siemens Medical Solutions USA, Inc.20235—
+9K220619Vivid S60N, Vivid S70NGE Medical Systems Ultrasound and Primary Care Diagnostics202222
+9K220358Voluson Expert 22, Voluson Expert 20, Voluson Expert 18GE Medical Systems Ultrasound and Primary Care Diagnostics20223—
+9K211665SONON Ultrasound Imaging System, Model: SONON300CHealcerion Co., Ltd.20220—
+9K220243Ultiri Measurement SystemAbbott Medical20220—
+9K212400SONON Ultrasound Imaging System, Model: SONON 500LHealcerion Co., Ltd.20220—
+9K220490ImaCor Zura Handheld ZHH-010Imacor, Inc.202202
+9K211746Pocket Ultrasound SystemGuangdong Youkey Medical Co., Ltd.20221—
+9K212012Follicle ClarityCycle Clarity20221—
+9K213436Clarius Ultrasound ScannerClarius Mobile Health Corp.20212—
+9K211161Critical Care Suite with Endotracheal Tube Positing AI algorithmGe Medical Systems, LLC20211—
+9K211232Apache Ultrasound SystemAco Healthcare Co., Ltd.20210—
+9K202658Vivid E80/ Vivid E90/ Vivid E95GE Medical Systems Ultrasound and Primary Care Diagnostics20215—
+9K201881CoroFlow Cardiovascular SystemCoroventis Research AB20201—
+9K202074Apache Ultrasound System (Model C62)Compal Electronics, Inc.20200—
+9K2013523D Auto LAAPhilips Health Care20200—
+9K200356Medo AriaMedo.Ai20203—
+9K201012EPIQ Diagnostic Ultrasound System Series, Affiniti Diagnostic Ultrasound System Series…Philips Ultrasound, Inc.2020185
+9K192267ILUMIEN System with AptiVue Software version D.3Abbott Medical20190—
+9K190078IntraSightVolcano Corporation20192—
+9K172455CORE M2 Vascular System, CORE M2 Software v4.2 Upgrade Kit, CORE M2 Software v4.2…Volcano Corporation201701
+9K170133FFR V2.5Philips Volcano201751
+9K170385CORE M2 Vascular SystemVolcano Corporation20171—
+10K261849VERAFEYE Imaging Catheter (VF-VIC-002)Luma Vision Limited20260—
+10K260885VERAFEYE Imaging and Guidance System (VF-VIS-002)Luma Vision Limited20260—
+10K252332FolliscanMim Fertility20260—
+10K253502Critical Care Suite with Enteric Tube Positioning AI AlgorithmGe Medical Systems, LLC20260—
+10K253714IntraSight PlusPhilips Image Guided Therapy Corporation202601
+10K253457ACUSON Juniper Diagnostic Ultrasound System; ACUSON Juniper Select Diagnostic Ultrasound…Siemens Medical Solutions USA, Inc.20250—
+10K234042EFAI Bonesuite XR Bone Age Pro Assessment System (BAP-XR-100)Ever Fortune.Ai, Co., Ltd.20242—
+10K231930Digital Ultrasonic Diagnostic Imaging System (Model: F6)Guangdong Youkey Medical Co., Ltd.20240—
+10K231965Voluson Expert 22, Voluson Expert 20, Voluson Expert 18GE Medical Systems Ultrasound and Primary Care Diagnostics20232—
+10K232145ACUSON Sequoia Diagnostic Ultrasound System, ACUSON Sequoia Select Diagnostic Ultrasound…Siemens Medical Solutions USA, Inc.20234—