510(k) Report

Devices descending from K022896

104 later devices reach CSV12 Software Viewer through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K092204PMD ViewerSpencer Technologies20090—
+1K060992Syngo US WorkplaceSiemens Medical Solutions2006971
+1K052895Foursight Viewtool Image ViewerSiemens Medical Solutions USA, Inc.2005102—
+2K132062Esie Apps SuiteSiemens Medical Solutions USA, Inc.20133—
+2K091286Syngo US WorkplaceSiemens Medical Solutions USA, Inc.200995—
+2K082135ShowcaseTrillium Technology, Inc.20080—
+3K161382LVivo Software ApplicationDiacardio, Ltd.20160—
+3K141554Esie Apps SuiteSiemens Medical Solutions USA, Inc.20142—
+3K130159Qlab Quantification Software Heart ModelPhilips Health Care201392—
+3K110447EchoinsightUltrasound Medical Devices, Inc.20110—
+4K143254eSie Apps SuiteSiemens Medical Solutions USA, Inc.20141—
+4K132165Qlab Quantification SoftwarePhilips Ultrasound, Inc.2013911
+5K201062syngo Ultrasound Apps Suite (sUSAS)Siemens Medical Solutions USA, Inc.20200—
+5K172162ACUSON S3000 S2000 S1000 Diagnostic Ultrasound SystemsSiemens Healthcare201743—
+5K171314QLAB Advanced Quantification SoftwarePhilips Health Care201745—
+5K170069AmCAD-UVAmcad Biomed Corporation20170—
+6K210743ACUSON Redwood Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.2021153
+6K202683ACUSON Sequoia Diagnostic Ultrasound System, ACUSON SC2000 Diagnostic Ultrasound System…Siemens Medical Solutions USA, Inc.20206—
+6K201462ACUSON Sequoia Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.2020241
+6K200707ACUSON Sequoia Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.202025—
+6K193257ACUSON Sequoia Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.2020261
+6K183575ACUSON S3000, S2000 Diagnostic Ultrasound SystemSiemens Healthineers201926—
+6K181264QLAB Advanced Quantification SoftwarePhilips Ultrasound, Inc.201844—
+6K180799Clarius Ultrasound ScannerClarius Mobile Health Corp.201811—
+6K180067ACUSON X800 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.201828—
+7K260748ES-SeriesE-Scopics20260—
+7K250120GECHONarnar, LLC20250—
+7K243299ACUSON Redwood Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.20240—
+7K221190ACUSON Juniper Diagnostic Ultrasound System and ACUSON Juniper Select Diagnostic…Siemens Medical Solutions USA, Inc.20224—
+7K221500ACUSON Sequoia Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.20226—
+7K212851EchoSK and EchoSGyn modules for EchoS Family devicesEcholight S.P.A20220—
+7K213487ACUSON P500 Ultrasound SystemSiemens Medical Solutions USA, Inc.20221—
+7K211726Acuson SC2000 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.20214—
+7K211859ACUSON Sequoia Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.202171
+7K191647QLAB Advanced Quantification SoftwarePhilips Health Care201941—
+7K192107Clarius Ultrasound ScannerClarius Mobile Health Corp.201910—
+7K191922ACUSON P200 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.201923—
+7K190913QLAB Advanced Quantification Software 13Philips Health Care20191—
+8K262548EPIQ Inspira Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound…Philips Ultrasound, LLC20260—
+8K242893VERAFEYE System VERAFEYE Imaging Catheter & VERAFEYE Imaging SystemLuma Vision Limited20252—
+8K233613ACUSON SC2000 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.20240—
+8K233610ACUSON P500 Ultrasound System; ACUSON P500 ICE Ultrasound SystemSiemens Medical Solutions USA, Inc.20240—
+8K230207ACUSON Juniper Diagnostic Ultrasound System, ACUSON Juniper Select Diagnostic Ultrasound…Siemens Medical Solutions USA, Inc.20233—
+8K223735ACUSON Sequoia Diagnostic Ultrasound System, ACUSON Sequoia Select Diagnostic Ultrasound…Siemens Medical Solutions USA, Inc.20235—
+8K211665SONON Ultrasound Imaging System, Model: SONON300CHealcerion Co., Ltd.20220—
+8K212400SONON Ultrasound Imaging System, Model: SONON 500LHealcerion Co., Ltd.20220—
+8K220490ImaCor Zura Handheld ZHH-010Imacor, Inc.202202
+8K211746Pocket Ultrasound SystemGuangdong Youkey Medical Co., Ltd.20221—
+8K212012Follicle ClarityCycle Clarity20221—
+8K213436Clarius Ultrasound ScannerClarius Mobile Health Corp.20212—
+8K211161Critical Care Suite with Endotracheal Tube Positing AI algorithmGe Medical Systems, LLC20211—
+8K211232Apache Ultrasound SystemAco Healthcare Co., Ltd.20210—
+8K202074Apache Ultrasound System (Model C62)Compal Electronics, Inc.20200—
+8K2013523D Auto LAAPhilips Health Care20200—
+8K200356Medo AriaMedo.Ai20203—
+8K200974QLAB Advanced Quantification SoftwarePhilips Health Care202012—
+8K201012EPIQ Diagnostic Ultrasound System Series, Affiniti Diagnostic Ultrasound System Series…Philips Ultrasound, Inc.2020185
+9K261849VERAFEYE Imaging Catheter (VF-VIC-002)Luma Vision Limited20260—
+9K260885VERAFEYE Imaging and Guidance System (VF-VIS-002)Luma Vision Limited20260—
+9K252332FolliscanMim Fertility20260—
+9K253502Critical Care Suite with Enteric Tube Positioning AI AlgorithmGe Medical Systems, LLC20260—
+9K253457ACUSON Juniper Diagnostic Ultrasound System; ACUSON Juniper Select Diagnostic Ultrasound…Siemens Medical Solutions USA, Inc.20250—
+9K234042EFAI Bonesuite XR Bone Age Pro Assessment System (BAP-XR-100)Ever Fortune.Ai, Co., Ltd.20242—
+9K231930Digital Ultrasonic Diagnostic Imaging System (Model: F6)Guangdong Youkey Medical Co., Ltd.20240—
+9K232145ACUSON Sequoia Diagnostic Ultrasound System, ACUSON Sequoia Select Diagnostic Ultrasound…Siemens Medical Solutions USA, Inc.20234—
+9K231509Aco Apache Ultrasound SystemAco Healthcare Co., Ltd.20230—
+9K232704Clarius Ultrasound ScannerClarius Mobile Health Corp.20230—
+9K232617ACUSON Maple Diagnostic Ultrasound System, ACUSON Maple Select Diagnostic Ultrasound…Siemens Medical Solutions USA, Inc.202312
+9K211597EPIQ Series Diagnostic Ultrasound System, Affiniti Series Diagnostic Ultrasound SystemPhilips Medical Systems202117—
+9K200603AAA ModelPhilips Ultrasound, Inc.20200—
+9K201632Tomtec-ArenaTomtec Imaging Systems GmbH202010—
+10K262390BoneXpertVisiana20260—
+10K251417ReVISION 2Argus Cognitive, Inc.20260—
+10K250914MediAI-BACrescom Co., Ltd.20250—
+10K253487ACUSON Maple Diagnostic Ultrasound System; ACUSON Maple Select Diagnostic Ultrasound…Siemens Medical Solutions USA, Inc.20250—
+10K240704ACUSON Sequoia Diagnostic Ultrasound System, ACUSON Sequoia Select Diagnostic Ultrasound…Siemens Medical Solutions USA, Inc.20243—
+10K233788EPIQ Series Diagnostic Ultrasound System, Affiniti Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC2024161
+10K223422Emory Cardiac Toolbox 4.3Syntermed20230—
+10K212376Caas QardiaPie Medical Imaging BV20220—
+10K213544Tomtec-ArenaTomtec Imaging Systems GmbH20226—
+11K2503303mensio WorkstationPie Medical Imaging BV202501
+11K241659Ultrasound Workspace (UWS 6.0)Philips Ultrasound, LLC20250—
+11K242523ACUSON Sequoia Diagnostic Ultrasound System; ACUSON Sequoia Select Diagnostic Ultrasound…Siemens Medical Solutions USA, Inc.20242—
+11K240980EPIQ Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC20240—
+11K240850EPIQ Series Diagnostic Ultrasound Systems; Affiniti Series Diagnostic Ultrasound SystemsPhilips Ultrasound, LLC202414—
+11K230209Sonix HealthOntact Health Co., Ltd.20233—
+12K251481ACUSON Sequoia Diagnostic Ultrasound System; ACUSON Sequoia Select Diagnostic Ultrasound…Siemens Medical Solutions USA, Inc.20251—
+12K251455EPIQ Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC20250—
+12K250886EPIQ Series Diagnostic Ultrasound Systems; Affiniti Series Diagnostic Ultrasound SystemsPhilips Ultrasound, LLC20250—
+12K243793EPIQ Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC20250—
+12K251110EPIQ Series Diagnostic Ultrasound Systems; Affiniti Series Diagnostic Ultrasound SystemsPhilips Ultrasound, LLC20250—
+12K243684BrightHeart View ClassifierBrightheart20251—
+12K243794EPIQ Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC20255—
+12K242020EPIQ Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC20243—
+12K240645Sonix HealthOntact Health Co., Ltd.20240—
+13K260667Alturion Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC20261—
+13K260844ACUSON Sequoia Diagnostic Ultrasound System;ACUSON Sequoia Select Diagnostic Ultrasound…Siemens Medical Solutions USA, Inc.20260—
+13K260680EPIQ Series Diagnostic Ultrasound Systems; Affiniti Series Diagnostic Ultrasound SystemsPhilips Ultrasound, LLC202601
+13K253595EPIQ Series Diagnostic Ultrasound System, Affiniti Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC20261—
+13K251456BrightHeart View ClassifierBrightheart20250—