510(k) Report

Devices descending from K130159

92 later devices reach Qlab Quantification Software Heart Model through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K132165Qlab Quantification SoftwarePhilips Ultrasound, Inc.2013911
+2K172162ACUSON S3000 S2000 S1000 Diagnostic Ultrasound SystemsSiemens Healthcare201743—
+2K171314QLAB Advanced Quantification SoftwarePhilips Health Care201745—
+2K170069AmCAD-UVAmcad Biomed Corporation20170—
+3K210743ACUSON Redwood Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.2021153
+3K202683ACUSON Sequoia Diagnostic Ultrasound System, ACUSON SC2000 Diagnostic Ultrasound System…Siemens Medical Solutions USA, Inc.20206—
+3K201462ACUSON Sequoia Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.2020241
+3K200707ACUSON Sequoia Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.202025—
+3K193257ACUSON Sequoia Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.2020261
+3K183575ACUSON S3000, S2000 Diagnostic Ultrasound SystemSiemens Healthineers201926—
+3K181264QLAB Advanced Quantification SoftwarePhilips Ultrasound, Inc.201844—
+3K180799Clarius Ultrasound ScannerClarius Mobile Health Corp.201811—
+3K180067ACUSON X800 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.201828—
+4K260748ES-SeriesE-Scopics20260—
+4K250120GECHONarnar, LLC20250—
+4K243299ACUSON Redwood Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.20240—
+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—
+4K212851EchoSK and EchoSGyn modules for EchoS Family devicesEcholight S.P.A20220—
+4K213487ACUSON P500 Ultrasound SystemSiemens Medical Solutions USA, Inc.20221—
+4K211726Acuson SC2000 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.20214—
+4K211859ACUSON Sequoia Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.202171
+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—
+5K262548EPIQ Inspira Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound…Philips Ultrasound, LLC20260—
+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—
+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—
+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—
+5K200356Medo AriaMedo.Ai20203—
+5K200974QLAB Advanced Quantification SoftwarePhilips Health Care202012—
+5K201012EPIQ Diagnostic Ultrasound System Series, Affiniti Diagnostic Ultrasound System Series…Philips Ultrasound, Inc.2020185
+6K261849VERAFEYE Imaging Catheter (VF-VIC-002)Luma Vision Limited20260—
+6K260885VERAFEYE Imaging and Guidance System (VF-VIS-002)Luma Vision Limited20260—
+6K252332FolliscanMim Fertility20260—
+6K253502Critical Care Suite with Enteric Tube Positioning AI AlgorithmGe Medical Systems, LLC20260—
+6K253457ACUSON Juniper Diagnostic Ultrasound System; ACUSON Juniper Select Diagnostic Ultrasound…Siemens Medical Solutions USA, Inc.20250—
+6K234042EFAI Bonesuite XR Bone Age Pro Assessment System (BAP-XR-100)Ever Fortune.Ai, Co., Ltd.20242—
+6K231930Digital Ultrasonic Diagnostic Imaging System (Model: F6)Guangdong Youkey Medical Co., Ltd.20240—
+6K232145ACUSON Sequoia Diagnostic Ultrasound System, ACUSON Sequoia Select Diagnostic Ultrasound…Siemens Medical Solutions USA, Inc.20234—
+6K231509Aco Apache Ultrasound SystemAco Healthcare Co., Ltd.20230—
+6K232704Clarius Ultrasound ScannerClarius Mobile Health Corp.20230—
+6K232617ACUSON Maple Diagnostic Ultrasound System, ACUSON Maple Select Diagnostic Ultrasound…Siemens Medical Solutions USA, Inc.202312
+6K211597EPIQ Series Diagnostic Ultrasound System, Affiniti Series Diagnostic Ultrasound SystemPhilips Medical Systems202117—
+6K200603AAA ModelPhilips Ultrasound, Inc.20200—
+6K201632Tomtec-ArenaTomtec Imaging Systems GmbH202010—
+7K262390BoneXpertVisiana20260—
+7K251417ReVISION 2Argus Cognitive, Inc.20260—
+7K250914MediAI-BACrescom Co., Ltd.20250—
+7K253487ACUSON Maple Diagnostic Ultrasound System; ACUSON Maple Select Diagnostic Ultrasound…Siemens Medical Solutions USA, Inc.20250—
+7K240704ACUSON Sequoia Diagnostic Ultrasound System, ACUSON Sequoia Select Diagnostic Ultrasound…Siemens Medical Solutions USA, Inc.20243—
+7K233788EPIQ Series Diagnostic Ultrasound System, Affiniti Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC2024161
+7K223422Emory Cardiac Toolbox 4.3Syntermed20230—
+7K212376Caas QardiaPie Medical Imaging BV20220—
+7K213544Tomtec-ArenaTomtec Imaging Systems GmbH20226—
+8K2503303mensio WorkstationPie Medical Imaging BV202501
+8K241659Ultrasound Workspace (UWS 6.0)Philips Ultrasound, LLC20250—
+8K242523ACUSON Sequoia Diagnostic Ultrasound System; ACUSON Sequoia Select Diagnostic Ultrasound…Siemens Medical Solutions USA, Inc.20242—
+8K240980EPIQ Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC20240—
+8K240850EPIQ Series Diagnostic Ultrasound Systems; Affiniti Series Diagnostic Ultrasound SystemsPhilips Ultrasound, LLC202414—
+8K230209Sonix HealthOntact Health Co., Ltd.20233—
+9K251481ACUSON Sequoia Diagnostic Ultrasound System; ACUSON Sequoia Select Diagnostic Ultrasound…Siemens Medical Solutions USA, Inc.20251—
+9K251455EPIQ Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC20250—
+9K250886EPIQ Series Diagnostic Ultrasound Systems; Affiniti Series Diagnostic Ultrasound SystemsPhilips Ultrasound, LLC20250—
+9K243793EPIQ Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC20250—
+9K251110EPIQ Series Diagnostic Ultrasound Systems; Affiniti Series Diagnostic Ultrasound SystemsPhilips Ultrasound, LLC20250—
+9K243684BrightHeart View ClassifierBrightheart20251—
+9K243794EPIQ Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC20255—
+9K242020EPIQ Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC20243—
+9K240645Sonix HealthOntact Health Co., Ltd.20240—
+10K260667Alturion Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC20261—
+10K260844ACUSON Sequoia Diagnostic Ultrasound System;ACUSON Sequoia Select Diagnostic Ultrasound…Siemens Medical Solutions USA, Inc.20260—
+10K260680EPIQ Series Diagnostic Ultrasound Systems; Affiniti Series Diagnostic Ultrasound SystemsPhilips Ultrasound, LLC202601
+10K253595EPIQ Series Diagnostic Ultrasound System, Affiniti Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC20261—
+10K251456BrightHeart View ClassifierBrightheart20250—
+10K250177EPIQ Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC20252—
+11K262311Alturion Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC20260—
+11K251651EPIQ Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC20251—
+12K261211Philips EPIQ Series Diagnostic Ultrasound System; Philips Affiniti Series Diagnostic…Philips Ultrasound, LLC20260—