510(k) Report

Devices descending from K963807

242 later devices reach Tomtec Echo-Scan through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K190314Advanced Intelligent Volumetric Ultrasound System, Model AiVUS 1000Mednovel Technology, Ltd.20190—
+1K141870Breast Volume NavigatorMetritrack, LLC20142—
+1K140153Ventripoint Medical SystemVentripoint, Inc.20142—
+1K013088Echotech Easy 3D Family, Echotech 3D Freescan, Echotech Easyarchive, Echotech Quanticon…Echotech 3D Imaging Systems, Inc.20023—
+1K992886Powerview Ultrasound Workstation, Uidm-400AToshiba America Medical Systems, In.C1999212—
+1K993394Echo Scan, Easy ScanTomtec Imaging Systems GmbH199990—
+1K980308Echotech 3D FreescanEchotech 3D Imaging Systems GmbH199810—
+2K211098Breast Volume Navigator (BVN) Model G-2000Metritrack, Inc.20210—
+2K150628VentriPoint Medical SystemVentripoint, Inc.20151—
+2K060035MdxnetCybermdx, Inc.20060—
+2K030635The Obsidian Pacs SystemObsidian Medical Technology, Inc.20031—
+2K023473Sonoreal 3DBio Medi Com20021—
+2K022400Ssa-700A, Aplio Diagnostic Ultrasound SystemToshiba America Medical Systems, In.C20022101
+2K020561Sono-Scan, Sono-Scan Pro, Cardio ScanTomtec Imaging Systems GmbH200280—
+2K020068Sonoreal 3D SystemBio Medi Com20022—
+2K013633Ssa-770A, Aplio Ultrasound SystemToshiba America Medical Systems, In.C2001211—
+2K012084Sonoreal 3DBio Medi Com20013—
+2K011582Qcu Analytical Software PackageMedis Medical Imaging Systems BV20018—
+2K994385Baby FaceSonora Medical Systems20004—
+3K173810Ventripoint Medical System Plus (VMS+)Ventripoint Diagnostics, Ltd.20180—
+3K1105954D Sono-Scan 1.0Tomtec Imaging Systems GmbH201179—
+3K092842EchoplaqueIndec Systems, Inc.20102—
+3K062985Ivus EnhancerIndec Systems, Inc.20060—
+3K053306IVIEWOndemandsoft20060—
+3K042620Sonata 3-D Imaging Accessory, Model 3DSTetrad Corp.20040—
+3K0315673D Invivo by CsistChung-Shan Institute of Science and Technology20030—
+3K032281Ssa-770A - Version 4, Aplio Diagnostic Ultrasound SystemToshiba America Medical Systems, In.C2003209—
+3K022940IN-Vision View with Measurements Module, Model 1.0Intelligent Images Srl20023—
+3K021495QIVAPie Medical Imaging BV20023—
+4K132544Tomtec-Arena 1.0, Tomtec-Arena 3D Echo, Cardio-ArenaTomtec Imaging Systems GmbH201378—
+4K123970Caas IntravascularPie Medical Imaging BV20131—
+4K063130Aplio XG Diagnostic Ultrasound System, Model Ssa-790A, Version 1.0Toshibamedical Systems Corporation20062051
+4K041581Compacs, Version 1.0Intelligent Images Srl20041—
+4K041499Ssa-770A, Aplio Version 5.5Toshibamedical Systems Corporation200423
+5K210931Libby IAAA v1.0Dyad Medical, Inc.20210—
+5K200232LVivo Software ApplicationDia Imaging Analysis, Ltd.202019—
+5K192372ASCEND Image ViewerAscend Hit20200—
+5K150122Tomtec-Arena TTA2Tomtec Imaging Systems GmbH2015561
+5K120514CardiopacsLumedx20120—
+5K072826Aplio Artida Diagnostic Ultrasound SystemToshiba America Medical Systems, In.C2007182—
+5K072000Aplio XG Diagnostic Ultrasound System, Model Ssa-790A Version 2.0Toshiba America Medical Systems, In.C2007203—
+5K053043Encompass Software PackageToshiba America Medical Systems, In.C20050—
+5K050380Xario Diagnostic Ultrasound System, Model Ssa-660AToshiba America Medical Systems, In.C200502
+6K223322Argus Cognitive ReVISION SoftwareArgus Cognitive, Inc.20231—
+6K222406Clarius AIClarius Mobile Health Corp.20233—
+6K210053LVivo Software ApplicationDia Imaging Analysis, Ltd.202111—
+6K202546LVivo SeamlessDia Imaging Analysis, Ltd.20202—
+6K201632Tomtec-ArenaTomtec Imaging Systems GmbH202010—
+6K200974QLAB Advanced Quantification SoftwarePhilips Health Care202012—
+6K191171EchoGo CoreUltromics, Ltd.20193—
+6K170878Vivid S60N, Vivid S70NGE Medical Systems Ultrasound & Primary Care Diagnostics, LLC2017102
+6K170847EchoPAC Software Only, EchoPAC Plug-inGE Medical Systems Ultrasound and Primary Care Diagnostics20174—
+6K170823Vivid E80, Vivid E90, Vivid E95GE Medical Systems Ultrasound and Primary Care Diagnostics2017353
+6K151451Aplio 500/400/300 Diagnostic Ultrasound System V6.0Toshibamedical Systems Corporation2015342
+6K081065Aplio XG Diagnostic Ultrasound System, Model Ssa - 790A, Version 2.2Toshiba America Medical Systems, In.C2008118—
+6K080160Aplio Artida, Model SSH-880CV Diagnostic Ultrasound SystemToshiba America Medical Systems, In.C2008181—
+6K072918Model Ssa-680A Xario XG Diagnostic Ultrasound System, Version 1.00Toshibamedical Systems Corporation200703
+7K251417ReVISION 2Argus Cognitive, Inc.20260—
+7K260192DIANAROPCA ApS20260—
+7K260234MSK GoSmart Alfa Teknoloji San. Ve Tic. A.S.20260—
+7K252235PVAD IQ SoftwareUltrasight, Ltd.20250—
+7K250670EchoConfidence (USA)Mycardium AI Limited20250—
+7K250226Clarius Median Nerve AIClarius Mobile Health Corp.20250—
+7K242359Strain AI (SAI001)Exo, Inc.20240—
+7K232501AI Platform (AIP001)Exo, Inc.20231—
+7K223422Emory Cardiac Toolbox 4.3Syntermed20230—
+7K222970LVivo IQSDia Imaging Analysis, Ltd.20236—
+7K212376Caas QardiaPie Medical Imaging BV20220—
+7K213544Tomtec-ArenaTomtec Imaging Systems GmbH20226—
+7K213275EchoGo Core (2.0)Ultromics Limited20211—
+7K212466LVivo SeamlessDia Imaging Analysis, Ltd.20211—
+7K200603AAA ModelPhilips Ultrasound, Inc.20200—
+7K200852EchoPAC Software Only, EchoPAC Plug-InGE Medical Systems Ultrasound and Primary Care Diagnostics20203—
+7K181727Vivid iqGE Medical Systems Ultrasound and Primary Care Diagnostics20189—
+7K181934Vivid T8, Vivid T9GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC20183—
+7K182450Vivid S60N, Vivid S70NGE Medical Systems Ultrasound and Primary Care Diagnostics201892
+7K173341Vivid E80, Vivid E90, Vivid E95GE Medical Systems2017203
+7K163702Aplio i900/i800/i700 Diagnostic Ultrasound System, V2.1Toshibamedical Systems Corporation2017221
+7K1630826200 Ultrasound System and 6250 Ultrasound SystemEsaote, S.p.A.201792
+7K161843Aplio i900/i800/i700 Diagnostic Ultrasound System, V2.0Toshibamedical Systems Corporation2016231
+7K090158Aplio Artida V2.0 SSH-880CVToshiba America Medical Systems, In.C2009985
+7K0826844D Viewer Radiology, Model Uswp-100AToshiba America Medical Systems, In.C20080—
+7K082596Ultraextend Usws-900AToshiba America Medical Systems, In.C200882—
+7K082119Aplio XG Diagnostic Ultrasound System, Model Ssa - 790A Version 3.0Toshiba America Medical Systems, In.C2008116—
+8K2503303mensio WorkstationPie Medical Imaging BV202501
+8K252007BlineSlideDeep Breathe, Inc.20250—
+8K243331LVivo SeamlessDia Imaging Analysis, Ltd.20250—
+8K241659Ultrasound Workspace (UWS 6.0)Philips Ultrasound, LLC20250—
+8K240553LVivo Software ApplicationDia Imaging Analysis, Ltd.20242—
+8K240953AI Platform 2.0 (AIP002)Exo Imaging20241—
+8K234141AISAP Cardio V1.0Aisap20240—
+8K240769LVivo IQSDia Imaging Analysis, Ltd.20240—
+8K230209Sonix HealthOntact Health Co., Ltd.20233—
+8K220940EchoPAC Software Only, EchoPAC Plug-inGE Medical Systems Ultrasound and Primary Care Diagnostics20222—
+8K200708Vivid iqGe Medical Systems Ultrasound And20203—
+8K200851Vivid T8, Vivid T9GE Medical Systems Ultrasound and Primary Care Diagnostics20202—
+8K200497Vivid S60N, Vivid S70NGE Medical Systems Ultrasound and Primary Care Diagnostics202042
+8K191798Versana ActiveGE Medical Systems Ultrasound and Primary Care Diagnostics20191—
+8K191792Versana BalanceGE Medical Systems Ultrasound and Primary Care Diagnostics20193—
+8K181685Vivid E80, Vivid E90, Vivid E95GE Medical Systems Ultrasound and Primary Care Diagnostics201813—