510(k) Report

Devices descending from K990248

213 later devices reach Dicom Image Manager, Model 3-D Visualization Option through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K992886Powerview Ultrasound Workstation, Uidm-400AToshiba America Medical Systems, In.C1999212—
+2K022400Ssa-700A, Aplio Diagnostic Ultrasound SystemToshiba America Medical Systems, In.C20022101
+2K013633Ssa-770A, Aplio Ultrasound SystemToshiba America Medical Systems, In.C2001211—
+3K032281Ssa-770A - Version 4, Aplio Diagnostic Ultrasound SystemToshiba America Medical Systems, In.C2003209—
+4K063130Aplio XG Diagnostic Ultrasound System, Model Ssa-790A, Version 1.0Toshibamedical Systems Corporation20062051
+4K041499Ssa-770A, Aplio Version 5.5Toshibamedical Systems Corporation200423
+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
+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
+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—
+8K1732916440 Ultrasound SystemEsaote, S.p.A.20188—
+8K173090Aplio i900/i800/i700/i600 Diagnostic Ultrasound System, V2.4Toshibamedical Systems Corporation201821—
+8K131822Ultraextend Usws-900A V2.1 and V3.1Toshiba America Medical Systems, In.C20130—
+8K121577Aplio Artida Diagnostic Ultrasound SystemToshiba Medical Systems Corporation, Japan201229—
+8K110870Aplio Diagnostic Ultrasound System; Aplio Diagnostic Ultrasound System; Aplio Diagnostic…Toshiba America Medical Systems, In.C201189—
+8K1107464D LV-Analysis 3.0Tomtec Imaging Systems GmbH201180—
+8K091295Aplio XG Diagnostic Ultrasound System Model Ssa-790A Version 4.0Toshiba America Medical Systems, In.C2009222
+9K2301796440 MyLabX90Esaote, S.p.A.202341
+9K1921576450 Ultrasound systemEsaote, S.p.A.20194—
+9K191007Aixplorer MACH 30, Aixplorer MACH 20 Ultrasound Diagnostic SystemsSupersonic Imagine20195—
+9K1831916420 Ultrasound SystemEsaote, S.p.A.20180—
+9K182427Aplio a550 and a450, Software V2.8 Diagnostic Ultrasound SystemCanon Medical Systems Corporation20184—
+9K182679Aplio i900/i800/i700/i600 Diagnostic Ultrasound System, V3.1Canon Medical Systems Corporation201810—
+9K140729Aplio Artida, V3.2Toshiba America Medical Systems, In.C201428—
+9K132544Tomtec-Arena 1.0, Tomtec-Arena 3D Echo, Cardio-ArenaTomtec Imaging Systems GmbH201378—
+9K120282CardnavPaieon, Inc.20120—
+9K121076Ultraextend FX, Ultrasound Workstation PackageToshiba America Medical Systems, In.C20122—
+9K121422Aplio 500/400/300 Diagnostic Ultrasound SystemToshiba Medical Systems Coporation, Japan201285—
+9K100067Model Viamo Ssa-640A, Version 2.0 Ultrasound SystemToshiba America Medical Systems, In.C20101—
+9K093171Viamo Ssa-640A Version 1.2Toshiba America Medical Systems, In.C200911—
+9K092948Aplio MX Ssa-780A, Version 1.0Toshiba America Medical Systems, In.C200901
+9K092179Aplio XG Diagnostic Ultrasound System, Model Ssa - 790A Version 4.0R001Toshiba America Medical Systems, In.C200991
+10K261272ePascal S/ ePascal SOR/ ePascal S5/ ePascal SA/ ePascal SE/ ePascal 80Elite/ ePascal 80/…Esonic Technology (Wuhan) Co., Ltd.20260—
+10K2432536600 Ultrasound System (MyLabA50); 6600 Ultrasound System (MyLabA70)Esaote, S.p.A.20252—
+10K2416716450 Ultrasound System (MyLabE80); 6450 Ultrasound System (MyLabE85)Esaote, S.p.A.20252—
+10K250328UltraExtend NX CUW-U001S V2.0 Ultrasound Image Analysis ProgramCanon Medical Systems Corporation20250—
+10K2120216430 MyLabX75, 6430 MyLab XPro75Esaote, S.p.A.20210—
+10K203645Aixplorer MACH30/ SUPERSONIC MACH30, Aixplorer MACH20/ SUPERSONIC MACH20, SUPERSONIC…Supersonic Imagine20212—
+10K202455Aixplorer®MACH20, Aixplorer®MACH30, Supersonic MACH40, Supersonic MACH30 & Supersoinc…Supersonic Imagine20200—
+10K200232LVivo Software ApplicationDia Imaging Analysis, Ltd.202019—
+10K192372ASCEND Image ViewerAscend Hit20200—
+10K191663Aplio a550, Aplio a450 and Aplio a, Diagnostic Ultrasound System, V4.0Canon Medical Systems Corporation20193—
+10K191467Aplio i900/i800/i700/i600 Diagnostic Ultrasound System, V4.0Canon Medical Systems Corporation20199—
+10K161960bk2300Bk Medical Aps20165—
+10K150122Tomtec-Arena TTA2Tomtec Imaging Systems GmbH2015561
+10K142197Ultrasound System Sonimage HS1, Linear Probe L18-4, Convex Probe C5-2Konica Minolta, Inc.201452
+10K132677Ultrasound Scanner Flex Focus 1202B-K Medical Aps20140—
+10K132685Ultrasound Scanner Pro Focus 2202B-K Medical Aps20140—
+10K123992Aplio 500/400/300 V3.0Toshibamedical Systems Corporation201382—
+10K122009Aida VI.8 Diagnostic Ultrasound GM-72P00A, L13-5V1 TransducerPanasonic Healthcare Co., Ltd.20120—
+10K111142Echosoft (TM)Echometrix, LLC20120—
+10K122491Viamo Ssa-640A V4.0Toshibamedical Systems Corporation20120—
+10K113612Aida V1.5 Diagnostic Ultrasound System GM-72P00APanasonic Healthcare Co., Ltd.20121—
+10K103148Aida Diagnostic Ultrasound SystemPanasonic Healthcare Co., Ltd.20112—
+10K103629Pet-512MC Transesophageal TransducerToshiba America Medical Systems, In.C20116—
+11K2532886450 Ultrasound System (MyLabE80); 6450 Ultrasound System (MyLabE85)Esaote, S.p.A.20260—
+11K2533107600 Ultrasound System (MyLabC25); 7600 Ultrasound System (MyLabC30)Esaote, S.p.A.20250—
+11K223322Argus Cognitive ReVISION SoftwareArgus Cognitive, Inc.20231—
+11K222406Clarius AIClarius Mobile Health Corp.20233—
+11K222191Aixplorer MACH30 / SUPERSONIC MACH30, Aixplorer MACH20 / SUPERSONIC , MACH20, SUPERSONIC…Supersonic Imagine20221—
+11K210053LVivo Software ApplicationDia Imaging Analysis, Ltd.202111—
+11K202737Aplio i900/i800/i700/i600 Diagnostic Ultrasound System, Aplio a550, Aplio a450, and…Canon Medical Systems Corporation20200—
+11K202364Aplio a550, Aplio a450, Aplio a, Diagnostic Ultrasound System, Software V5.1Canon Medical Systems Corporation20201—
+11K201972Aplio i900/i800/i700 Diagnostic Ultrasound System, Software V5.1Canon Medical Systems Corporation20207—
+11K202546LVivo SeamlessDia Imaging Analysis, Ltd.20202—
+11K201632Tomtec-ArenaTomtec Imaging Systems GmbH202010—
+11K200974QLAB Advanced Quantification SoftwarePhilips Health Care202012—
+11K191171EchoGo CoreUltromics, Ltd.20193—
+11K180737Ultrasound Scanner System bk2300Bk Medical Aps20182—
+11K173569Ultrasound System 1300Bk Medical Aps20181—
+11K170878Vivid S60N, Vivid S70NGE Medical Systems Ultrasound & Primary Care Diagnostics, LLC2017102
+11K170847EchoPAC Software Only, EchoPAC Plug-inGE Medical Systems Ultrasound and Primary Care Diagnostics20174—
+11K170823Vivid E80, Vivid E90, Vivid E95GE Medical Systems Ultrasound and Primary Care Diagnostics2017353
+11K151060Ultrasound System SONIMAGE HS1Konica Minolta, Inc.201541
+11K133761Aplio 500/400/300 Diagnostic Ultrasound System V4.0Toshibamedical Systems Corporation201472—
+11K131507Xario 200 Diagnostic Ultrasound SystemToshibamedical Systems Corporation20139—
+12K251417ReVISION 2Argus Cognitive, Inc.20260—
+12K260192DIANAROPCA ApS20260—
+12K260234MSK GoSmart Alfa Teknoloji San. Ve Tic. A.S.20260—
+12K252235PVAD IQ SoftwareUltrasight, Ltd.20250—
+12K250670EchoConfidence (USA)Mycardium AI Limited20250—
+12K250226Clarius Median Nerve AIClarius Mobile Health Corp.20250—
+12K242359Strain AI (SAI001)Exo, Inc.20240—
+12K242223SuperSonic HepaVuSupersonic Imagine20240—
+12K232501AI Platform (AIP001)Exo, Inc.20231—
+12K231764Ultrasound System 1300Bk Medical Aps202301
+12K223422Emory Cardiac Toolbox 4.3Syntermed20230—
+12K222970LVivo IQSDia Imaging Analysis, Ltd.20236—
+12K222441Ultrasound System 2300Bk Medical Aps20221—