510(k) Report

Devices descending from K001592

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K042188Volcano Therapeutics, Inc. Volcano Ivus SystemVolcano Therapeutics, Inc.200448—
+1K040546Image-Arena and Research-Arena ApplicationsTomtec Imaging Systems GmbH2004184—
+2K103761Visualize: VascularThe Medipattern Corporation20110—
+2K072932Infraredix Nir Imaging System, Gen. 1.0, Model MC-5Infraredx, Inc.20081—
+2K071232Image-Arena Applications and Research-Arena ApplicationsTomtec Imaging Systems GmbH200794—
+2K061396Qlab Quantification SoftwarePhilips Ultrasound, Inc.20060—
+2K060992Syngo US WorkplaceSiemens Medical Solutions2006971
+2K051337Eagle Eye Gold Ivus Imaging Catheter, Model 85900/859XX; Volcano VH-Ivus System, Model…Volcano Corporation200547—
+2K041581Compacs, Version 1.0Intelligent Images Srl20041—
+3K132544Tomtec-Arena 1.0, Tomtec-Arena 3D Echo, Cardio-ArenaTomtec Imaging Systems GmbH201378—
+3K122289Image-Com 5.0Tomtec Imaging Systems GmbH201279—
+3K120514CardiopacsLumedx20120—
+3K1107464D LV-Analysis 3.0Tomtec Imaging Systems GmbH201180—
+3K1105954D Sono-Scan 1.0Tomtec Imaging Systems GmbH201179—
+3K1037824D MV-Assessment 2.0Tomtec Imaging Systems GmbH201179—
+3K093993Lipiscan Ivus Imaging System Model Nirs-MC7-70Infraredx, Inc.20100—
+3K091780Guided Measurement Catheter (GMC)Mediguide, Ltd.20091—
+3K091286Syngo US WorkplaceSiemens Medical Solutions USA, Inc.200995—
+3K083348Image-Arena ApplicationsTomtec Imaging Systems GmbH200889—
+3K082135ShowcaseTrillium Technology, Inc.20080—
+3K082510Image-Arena Applications, Model Image-Arena VA Platform 1.0, 4D LV-Analysis 2.5, 4D…Tomtec Imaging Systems GmbH20080—
+3K082596Ultraextend Usws-900AToshiba America Medical Systems, In.C200882—
+3K073473Eagle Eye Gold Ivus Imaging Catheter, Model 85900, Avabar F/X Ivus Imaging Catheter…Volcano Corporation200814—
+3K071554Volcano S5/S5I Intravascular Imaging and Pressure SystemVolcano Corporation2008282
+4K200232LVivo Software ApplicationDia Imaging Analysis, Ltd.202019—
+4K192372ASCEND Image ViewerAscend Hit20200—
+4K172258Novasight Hybrid SystemConavi Medical, Inc.20181Class I
+4K161382LVivo Software ApplicationDiacardio, Ltd.20160—
+4K150122Tomtec-Arena TTA2Tomtec Imaging Systems GmbH2015561
+4K142235CPS Aim MediGuide Enabled inner catheter, CPS Aim Mediguide Enabled inner CatheterSt Jude Medical20140—
+4K131822Ultraextend Usws-900A V2.1 and V3.1Toshiba America Medical Systems, In.C20130—
+4K130159Qlab Quantification Software Heart ModelPhilips Health Care201392—
+4K120282CardnavPaieon, Inc.20120—
+4K110447EchoinsightUltrasound Medical Devices, Inc.20110—
+4K110667Image-Arena and Image-Arena ApplicationsTomtec Imaging Systems GmbH201180—
+4K092596Eagle Eye Platinum Digital Ivus CatheterVolcano Corporation200913—
+4K090461Image-Arena 4.0 and IA Applications 2D Cardiac Performance Analysis 1.0Tomtec Imaging Systems GmbH2009861
+4K082229S5/S5I Series Intravascular Imaging and Pressure System, Combomap Pressure and Flow SystemVolcano Corporation2008253
+5K252945Novasight Hybrid SystemConavi Medical, Inc.20260—
+5K223322Argus Cognitive ReVISION SoftwareArgus Cognitive, Inc.20231—
+5K222406Clarius AIClarius Mobile Health Corp.20233—
+5K210053LVivo Software ApplicationDia Imaging Analysis, Ltd.202111—
+5K202546LVivo SeamlessDia Imaging Analysis, Ltd.20202—
+5K201632Tomtec-ArenaTomtec Imaging Systems GmbH202010—
+5K200974QLAB Advanced Quantification SoftwarePhilips Health Care202012—
+5K191171EchoGo CoreUltromics, Ltd.20193—
+5K170878Vivid S60N, Vivid S70NGE Medical Systems Ultrasound & Primary Care Diagnostics, LLC2017102
+5K170847EchoPAC Software Only, EchoPAC Plug-inGE Medical Systems Ultrasound and Primary Care Diagnostics20174—
+5K170823Vivid E80, Vivid E90, Vivid E95GE Medical Systems Ultrasound and Primary Care Diagnostics2017353
+5K143701Eagle Eye Platinum Catheter, Eagle Eye Platinum Short Tip Catheter, Visions PV .014…Volcano Corporation201510—
+5K132165Qlab Quantification SoftwarePhilips Ultrasound, Inc.2013911
+5K1201352D Cardiac Performance Analysis MR 1.0Tomtec Imaging Systems GmbH201282—
+5K120697Eagle Eye Platinum ST CatheterVolcano Corporation201212—
+5K111706Volcano S5IINTRAVASCULAR Imaging and Pressure SystemVolcano Corporation2011241
+6K251417ReVISION 2Argus Cognitive, Inc.20260—
+6K260192DIANAROPCA ApS20260—
+6K260234MSK GoSmart Alfa Teknoloji San. Ve Tic. A.S.20260—
+6K252235PVAD IQ SoftwareUltrasight, Ltd.20250—
+6K250670EchoConfidence (USA)Mycardium AI Limited20250—
+6K250226Clarius Median Nerve AIClarius Mobile Health Corp.20250—
+6K242359Strain AI (SAI001)Exo, Inc.20240—
+6K232661Myocardial Strain Software ApplicationCircle Cardiovascular Imaging20231—
+6K232501AI Platform (AIP001)Exo, Inc.20231—
+6K232584Vein360 Reprocessed Visions PV.014P Rx Digital IVUS Catheter, Vein360 Reprocessed Eagle…Vein 360, LLC20230—
+6K223422Emory Cardiac Toolbox 4.3Syntermed20230—
+6K222970LVivo IQSDia Imaging Analysis, Ltd.20236—
+6K210655Reprocessed Eagle Eye Platinum RX Digital IVUS CatheterInnovative Health, LLC20221—
+6K212376Caas QardiaPie Medical Imaging BV20220—
+6K213544Tomtec-ArenaTomtec Imaging Systems GmbH20226—
+6K213275EchoGo Core (2.0)Ultromics Limited20211—
+6K212466LVivo SeamlessDia Imaging Analysis, Ltd.20211—
+6K200603AAA ModelPhilips Ultrasound, Inc.20200—
+6K200852EchoPAC Software Only, EchoPAC Plug-InGE Medical Systems Ultrasound and Primary Care Diagnostics20203—
+6K200410Reconnaissance PV .018 OTW Digital IVUS CatheterPhilips Image Guided Therapy Corporation20201—
+6K191175ACIST Kodama Intravascular Ultrasound Catheter, ACIST HDi SystemAcist Medical Systems, Inc.20191—
+6K181727Vivid iqGE Medical Systems Ultrasound and Primary Care Diagnostics20189—
+6K181934Vivid T8, Vivid T9GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC20183—
+6K182450Vivid S60N, Vivid S70NGE Medical Systems Ultrasound and Primary Care Diagnostics201892
+6K173341Vivid E80, Vivid E90, Vivid E95GE Medical Systems2017203
+6K172162ACUSON S3000 S2000 S1000 Diagnostic Ultrasound SystemsSiemens Healthcare201743—
+6K171314QLAB Advanced Quantification SoftwarePhilips Health Care201745—
+6K170069AmCAD-UVAmcad Biomed Corporation20170—
+6K160583REFINITY Rotational IVUS Catheter, REFINITY Rotational IVUS Catheter, Short TipVolcano Corporation201602
+6K152829Visions PV.014P RX Digital IVUS CatheterVolcano Corporation201541
+6K131158CorviewMarrek, Inc.20130—
+6K123898Volcano S5/S5I Intravascular Ultrasound Imaging and Pressure SystemVolcano Corporation20132110
+6K113486Volcano S5I Intravascular Ultracound Imaging and Pressure SystemVolcano Corporation20122—
+7K2503303mensio WorkstationPie Medical Imaging BV202501
+7K253399Visions® PV .014P RX Digital IVUS Catheter ; Visions® PV .018 Digital IVUS CatheterVolcano Corporation (Dba Philips Image Guided Therapy Device20250—
+7K252007BlineSlideDeep Breathe, Inc.20250—
+7K243331LVivo SeamlessDia Imaging Analysis, Ltd.20250—
+7K241659Ultrasound Workspace (UWS 6.0)Philips Ultrasound, LLC20250—
+7K242781cvi42 Software ApplicationCircle Cardiovascular Imaging, Inc.20240—
+7K240553LVivo Software ApplicationDia Imaging Analysis, Ltd.20242—
+7K240953AI Platform 2.0 (AIP002)Exo Imaging20241—
+7K234141AISAP Cardio V1.0Aisap20240—
+7K240769LVivo IQSDia Imaging Analysis, Ltd.20240—
+7K233948Provisio™ SLT IVUS™ SystemProvisio Medical, Inc.20240—
+7K230209Sonix HealthOntact Health Co., Ltd.20233—
+7K223026NES Reprocessed Eagle Eye Platinum RX Digital IVUS CatheterNortheast Scientific, Inc.20230—