510(k) Report

Devices descending from K091286

95 later devices reach Syngo US Workplace through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K161382LVivo Software ApplicationDiacardio, Ltd.20160—
+1K130159Qlab Quantification Software Heart ModelPhilips Health Care201392—
+1K110447EchoinsightUltrasound Medical Devices, Inc.20110—
+2K132165Qlab Quantification SoftwarePhilips Ultrasound, Inc.2013911
+3K172162ACUSON S3000 S2000 S1000 Diagnostic Ultrasound SystemsSiemens Healthcare201743—
+3K171314QLAB Advanced Quantification SoftwarePhilips Health Care201745—
+3K170069AmCAD-UVAmcad Biomed Corporation20170—
+4K210743ACUSON Redwood Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.2021153
+4K202683ACUSON Sequoia Diagnostic Ultrasound System, ACUSON SC2000 Diagnostic Ultrasound System…Siemens Medical Solutions USA, Inc.20206—
+4K201462ACUSON Sequoia Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.2020241
+4K200707ACUSON Sequoia Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.202025—
+4K193257ACUSON Sequoia Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.2020261
+4K183575ACUSON S3000, S2000 Diagnostic Ultrasound SystemSiemens Healthineers201926—
+4K181264QLAB Advanced Quantification SoftwarePhilips Ultrasound, Inc.201844—
+4K180799Clarius Ultrasound ScannerClarius Mobile Health Corp.201811—
+4K180067ACUSON X800 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.201828—
+5K260748ES-SeriesE-Scopics20260—
+5K250120GECHONarnar, LLC20250—
+5K243299ACUSON Redwood Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.20240—
+5K221190ACUSON Juniper Diagnostic Ultrasound System and ACUSON Juniper Select Diagnostic…Siemens Medical Solutions USA, Inc.20224—
+5K221500ACUSON Sequoia Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.20226—
+5K212851EchoSK and EchoSGyn modules for EchoS Family devicesEcholight S.P.A20220—
+5K213487ACUSON P500 Ultrasound SystemSiemens Medical Solutions USA, Inc.20221—
+5K211726Acuson SC2000 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.20214—
+5K211859ACUSON Sequoia Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.202171
+5K191647QLAB Advanced Quantification SoftwarePhilips Health Care201941—
+5K192107Clarius Ultrasound ScannerClarius Mobile Health Corp.201910—
+5K191922ACUSON P200 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.201923—
+5K190913QLAB Advanced Quantification Software 13Philips Health Care20191—
+6K262548EPIQ Inspira Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound…Philips Ultrasound, LLC20260—
+6K242893VERAFEYE System VERAFEYE Imaging Catheter & VERAFEYE Imaging SystemLuma Vision Limited20252—
+6K233613ACUSON SC2000 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.20240—
+6K233610ACUSON P500 Ultrasound System; ACUSON P500 ICE Ultrasound SystemSiemens Medical Solutions USA, Inc.20240—
+6K230207ACUSON Juniper Diagnostic Ultrasound System, ACUSON Juniper Select Diagnostic Ultrasound…Siemens Medical Solutions USA, Inc.20233—
+6K223735ACUSON Sequoia Diagnostic Ultrasound System, ACUSON Sequoia Select Diagnostic Ultrasound…Siemens Medical Solutions USA, Inc.20235—
+6K211665SONON Ultrasound Imaging System, Model: SONON300CHealcerion Co., Ltd.20220—
+6K212400SONON Ultrasound Imaging System, Model: SONON 500LHealcerion Co., Ltd.20220—
+6K220490ImaCor Zura Handheld ZHH-010Imacor, Inc.202202
+6K211746Pocket Ultrasound SystemGuangdong Youkey Medical Co., Ltd.20221—
+6K212012Follicle ClarityCycle Clarity20221—
+6K213436Clarius Ultrasound ScannerClarius Mobile Health Corp.20212—
+6K211161Critical Care Suite with Endotracheal Tube Positing AI algorithmGe Medical Systems, LLC20211—
+6K211232Apache Ultrasound SystemAco Healthcare Co., Ltd.20210—
+6K202074Apache Ultrasound System (Model C62)Compal Electronics, Inc.20200—
+6K2013523D Auto LAAPhilips Health Care20200—
+6K200356Medo AriaMedo.Ai20203—
+6K200974QLAB Advanced Quantification SoftwarePhilips Health Care202012—
+6K201012EPIQ Diagnostic Ultrasound System Series, Affiniti Diagnostic Ultrasound System Series…Philips Ultrasound, Inc.2020185
+7K261849VERAFEYE Imaging Catheter (VF-VIC-002)Luma Vision Limited20260—
+7K260885VERAFEYE Imaging and Guidance System (VF-VIS-002)Luma Vision Limited20260—
+7K252332FolliscanMim Fertility20260—
+7K253502Critical Care Suite with Enteric Tube Positioning AI AlgorithmGe Medical Systems, LLC20260—
+7K253457ACUSON Juniper Diagnostic Ultrasound System; ACUSON Juniper Select Diagnostic Ultrasound…Siemens Medical Solutions USA, Inc.20250—
+7K234042EFAI Bonesuite XR Bone Age Pro Assessment System (BAP-XR-100)Ever Fortune.Ai, Co., Ltd.20242—
+7K231930Digital Ultrasonic Diagnostic Imaging System (Model: F6)Guangdong Youkey Medical Co., Ltd.20240—
+7K232145ACUSON Sequoia Diagnostic Ultrasound System, ACUSON Sequoia Select Diagnostic Ultrasound…Siemens Medical Solutions USA, Inc.20234—
+7K231509Aco Apache Ultrasound SystemAco Healthcare Co., Ltd.20230—
+7K232704Clarius Ultrasound ScannerClarius Mobile Health Corp.20230—
+7K232617ACUSON Maple Diagnostic Ultrasound System, ACUSON Maple Select Diagnostic Ultrasound…Siemens Medical Solutions USA, Inc.202312
+7K211597EPIQ Series Diagnostic Ultrasound System, Affiniti Series Diagnostic Ultrasound SystemPhilips Medical Systems202117—
+7K200603AAA ModelPhilips Ultrasound, Inc.20200—
+7K201632Tomtec-ArenaTomtec Imaging Systems GmbH202010—
+8K262390BoneXpertVisiana20260—
+8K251417ReVISION 2Argus Cognitive, Inc.20260—
+8K250914MediAI-BACrescom Co., Ltd.20250—
+8K253487ACUSON Maple Diagnostic Ultrasound System; ACUSON Maple Select Diagnostic Ultrasound…Siemens Medical Solutions USA, Inc.20250—
+8K240704ACUSON Sequoia Diagnostic Ultrasound System, ACUSON Sequoia Select Diagnostic Ultrasound…Siemens Medical Solutions USA, Inc.20243—
+8K233788EPIQ Series Diagnostic Ultrasound System, Affiniti Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC2024161
+8K223422Emory Cardiac Toolbox 4.3Syntermed20230—
+8K212376Caas QardiaPie Medical Imaging BV20220—
+8K213544Tomtec-ArenaTomtec Imaging Systems GmbH20226—
+9K2503303mensio WorkstationPie Medical Imaging BV202501
+9K241659Ultrasound Workspace (UWS 6.0)Philips Ultrasound, LLC20250—
+9K242523ACUSON Sequoia Diagnostic Ultrasound System; ACUSON Sequoia Select Diagnostic Ultrasound…Siemens Medical Solutions USA, Inc.20242—
+9K240980EPIQ Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC20240—
+9K240850EPIQ Series Diagnostic Ultrasound Systems; Affiniti Series Diagnostic Ultrasound SystemsPhilips Ultrasound, LLC202414—
+9K230209Sonix HealthOntact Health Co., Ltd.20233—
+10K251481ACUSON Sequoia Diagnostic Ultrasound System; ACUSON Sequoia Select Diagnostic Ultrasound…Siemens Medical Solutions USA, Inc.20251—
+10K251455EPIQ Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC20250—
+10K250886EPIQ Series Diagnostic Ultrasound Systems; Affiniti Series Diagnostic Ultrasound SystemsPhilips Ultrasound, LLC20250—
+10K243793EPIQ Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC20250—
+10K251110EPIQ Series Diagnostic Ultrasound Systems; Affiniti Series Diagnostic Ultrasound SystemsPhilips Ultrasound, LLC20250—
+10K243684BrightHeart View ClassifierBrightheart20251—
+10K243794EPIQ Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC20255—
+10K242020EPIQ Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC20243—
+10K240645Sonix HealthOntact Health Co., Ltd.20240—
+11K260667Alturion Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC20261—
+11K260844ACUSON Sequoia Diagnostic Ultrasound System;ACUSON Sequoia Select Diagnostic Ultrasound…Siemens Medical Solutions USA, Inc.20260—
+11K260680EPIQ Series Diagnostic Ultrasound Systems; Affiniti Series Diagnostic Ultrasound SystemsPhilips Ultrasound, LLC202601
+11K253595EPIQ Series Diagnostic Ultrasound System, Affiniti Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC20261—
+11K251456BrightHeart View ClassifierBrightheart20250—
+11K250177EPIQ Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC20252—
+12K262311Alturion Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC20260—
+12K251651EPIQ Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC20251—
+13K261211Philips EPIQ Series Diagnostic Ultrasound System; Philips Affiniti Series Diagnostic…Philips Ultrasound, LLC20260—