510(k) Report

Devices descending from K963807

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+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
+9K260217AI Platform 2.2 (AIP002)Exo Imaging20260—
+9K251342EchoPAC Software Only / EchoPAC Plug-inGE Medical Systems Ultrasound and Primary Care Diagnostics20251—
+9K243684BrightHeart View ClassifierBrightheart20251—
+9K243862LVivo Software ApplicationDia Imaging Analysis, Ltd.20250—
+9K243235LVivo Software ApplicationDia Imaging Analysis, Ltd.20250—
+9K240645Sonix HealthOntact Health Co., Ltd.20240—
+9K2301796440 MyLabX90Esaote, S.p.A.202341
+9K221148Vivid iqGE Medical Systems Ultrasound & Primary Care Diagnostics, LLC20222—
+9K221147Vivid T8, Vivid T9GE Medical Systems Ultrasound and Primary Care Diagnostics20221—
+9K220446Versana BalanceGE Medical Systems Ultrasound and Primary Care Diagnostics20221—
+9K211216Vivid S60N / Vivid S70NGE Medical Systems Ultrasound and Primary Care Diagnostics202132
+9K201768Voluson E10GE Healthcare20204—
+9K200743Vivid E80/ Vivid E90/ Vivid E95Ge Medical Systems Ultrasound And20207—
+9K200998Versana ActiveGE Medical Systems Ultrasound and Primary Care Diagnostics20200—
+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—
+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
+10K261623EchoPAC Software Only / EchoPAC Plug-in (v211)GE Medical Systems Ultrasound and Primary Care Diagnostics20260—
+10K261272ePascal S/ ePascal SOR/ ePascal S5/ ePascal SA/ ePascal SE/ ePascal 80Elite/ ePascal 80/…Esonic Technology (Wuhan) Co., Ltd.20260—
+10K250913TINGSN FINDERS 2 Color Doppler Diagnostic Ultrasound SystemJiangsu Tingsn Technology Co., Ltd.20250—
+10K2432536600 Ultrasound System (MyLabA50); 6600 Ultrasound System (MyLabA70)Esaote, S.p.A.20252—
+10K251456BrightHeart View ClassifierBrightheart20250—
+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—
+10K243628Vivid T9/Vivid T8GE Medical Systems Ultrasound and Primary Care Diagnostics20250—
+10K243620Vivid iqGE Medical Systems Ultrasound and Primary Care Diagnostics20250—
+10K223407Versana EssentialGE Medical Systems Ultrasound and Primary Care Diagnostics20230—
+10K220619Vivid S60N, Vivid S70NGE Medical Systems Ultrasound and Primary Care Diagnostics202222
+10K220358Voluson Expert 22, Voluson Expert 20, Voluson Expert 18GE Medical Systems Ultrasound and Primary Care Diagnostics20223—
+10K2120216430 MyLabX75, 6430 MyLab XPro75Esaote, S.p.A.20210—
+10K203645Aixplorer MACH30/ SUPERSONIC MACH30, Aixplorer MACH20/ SUPERSONIC MACH20, SUPERSONIC…Supersonic Imagine20212—
+10K202658Vivid E80/ Vivid E90/ Vivid E95GE Medical Systems Ultrasound and Primary Care Diagnostics20215—
+10K202455Aixplorer®MACH20, Aixplorer®MACH30, Supersonic MACH40, Supersonic MACH30 & Supersoinc…Supersonic Imagine20200—
+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—
+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—
+11K231965Voluson Expert 22, Voluson Expert 20, Voluson Expert 18GE Medical Systems Ultrasound and Primary Care Diagnostics20232—
+11K223832Vivid S60N, Vivid S70NGe Medical System Ultrasound and Primary Care Diagnostics202312
+11K222191Aixplorer MACH30 / SUPERSONIC MACH30, Aixplorer MACH20 / SUPERSONIC , MACH20, SUPERSONIC…Supersonic Imagine20221—
+11K220882Vivid E80, Vivid E90, Vivid E95Ge Medical Systems Ultrasound And20222—
+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—
+11K180737Ultrasound Scanner System bk2300Bk Medical Aps20182—
+11K173569Ultrasound System 1300Bk Medical Aps20181—
+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—
+12K261313Vivid Explorer/Vivid Advanced/Vivid FocusGE Medical Systems Ultrasound and Primary Care Diagnostics20260—
+12K251169Vivid PioneerGE Medical Systems Ultrasound and Primary Care Diagnostics20250—
+12K242168Voluson Expert 18; Voluson Expert 20; Voluson Expert 22GE Medical Systems Ultrasound and Primary Care Diagnostics20241—
+12K242223SuperSonic HepaVuSupersonic Imagine20240—
+12K231764Ultrasound System 1300Bk Medical Aps202301
+12K222441Ultrasound System 2300Bk Medical Aps20221—
+12K212960Aplio a550, Aplio a450, and Aplio a, Diagnostic Ultrasound System, Software V6.5Canon Medical Systems Corporation202201
+12K212333Aplio i900/i800/i700 Diagnostic Ultrasound System, Software V6.5Canon Medical Systems Corporation202261
+12K161999AixplorerSupersonic Imagine201620—
+12K152577Ultrasound System Sonimage HS 1Konica Minolta, Inc.201532
+12K143027Xario 200, V3.0Toshibamedical Systems Corporation201451
+12K142517SoftVueDelphinus Medical Technologies, Inc.201449—
+12K141459Aplio 500/400/300 Diagnostic Ultrasound System, V5.0Toshibamedical Systems Corporation201439—
+12K133277XARIO 100Toshibamedical Systems Corporation20142—
+13K252328Voluson Expert 18; Voluson Expert 20; Voluson Expert 22GE Medical Systems Ultrasound and Primary Care Diagnostics20250—
+13K223830Ultrasound System 2300Bk Medical Aps202306
+13K223017Aplio i900/i800/i700 Diagnostic Ultrasound System, Software V7.0Canon Medical Systems Corporation20235—
+13K172256SoftVueDelphinus Medical Technologies20180—
+13K171105AIXPLORER® & AIXPLORER® Ultimate Ultrasound SystemsSupersonic Imagine201719—
+13K162372QT Ultrasound Breast Scanner-1Qt Ultrasound, LLC20174—
+13K162155Xario 200 Diagnostic Ultrasound System V5.0Toshibamedical Systems Corporation201641
+13K162065Ultrasound System SONIMAGE HS1Konica Minolta, Inc.201622
+13K150949FibroScanEchosens201542—