510(k) Report

Devices descending from K981397

403 later devices reach Harmonic Imaging and Flash Echo Imaging Function for the Diagnostic Ultrasound… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+10K201967SonoEye P2/ SonoEye V2/ SonoEye G2 Digital Color Doppler Palm Ultrasound SystemCHISON Medical Technologies Co., Ltd.20210—
+10K201968SonoEye P3/ SonoEye V3/ Sono Eye G3 Digital Color Doppler Palm Ultrasound SystemCHISON Medical Technologies Co., Ltd.20210—
+10K201971SonoEye P5/ SonoEye V5/ SonoEye G5 Digital Color Doppler Palm Ultrasound SystemCHISON Medical Technologies Co., Ltd.20210—
+10K201969SonoEye P6/ SonoEye V6/ SonoEye G6 Digital Color Doppler Palm Ultrasound SystemCHISON Medical Technologies Co., Ltd.20210—
+10K203406Lumify Diagnostic Ultrasound SystemPhilips Ultrasound, Inc.202143
+10K202455Aixplorer®MACH20, Aixplorer®MACH30, Supersonic MACH40, Supersonic MACH30 & Supersoinc…Supersonic Imagine20200—
+10K202406Butterfly iQ Ultrasound SystemButterfly Network, Inc.20205—
+10K200232LVivo Software ApplicationDia Imaging Analysis, Ltd.202019—
+10K201012EPIQ Diagnostic Ultrasound System Series, Affiniti Diagnostic Ultrasound System Series…Philips Ultrasound, Inc.2020185
+10K192372ASCEND Image ViewerAscend Hit20200—
+10K191663Aplio a550, Aplio a450 and Aplio a, Diagnostic Ultrasound System, V4.0Canon Medical Systems Corporation20193—
+10K192107Clarius Ultrasound ScannerClarius Mobile Health Corp.201910—
+10K191467Aplio i900/i800/i700/i600 Diagnostic Ultrasound System, V4.0Canon Medical Systems Corporation20199—
+10K180704SonoSite iViz Ultrasound SystemFUJIFILM Sonosite, Inc.20182—
+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—
+11K261081Pocket Ultrasound System (C10MTpro,C10MXpro,C10MSpro,C10MBpro,C10MRpro)Beijing Konted Medical Technology Co.,Ltd20260—
+11K2532886450 Ultrasound System (MyLabE80); 6450 Ultrasound System (MyLabE85)Esaote, S.p.A.20260—
+11K260595Sonosite iLOOK Ultrasound SystemFUJIFILM Sonosite, Inc.20260—
+11K251268Diagnostic Ultrasound System (Nano C5, Nano C5 EXP, Nano L12, and Nano L12 EXP)Edan Instruments, Inc.20250—
+11K2533107600 Ultrasound System (MyLabC25); 7600 Ultrasound System (MyLabC30)Esaote, S.p.A.20250—
+11K243628Vivid T9/Vivid T8GE Medical Systems Ultrasound and Primary Care Diagnostics20250—
+11K223322Argus Cognitive ReVISION SoftwareArgus Cognitive, Inc.20231—
+11K220068Butterfly iQ/iQ+ Ultrasound SystemButterfly Network, Inc.20232—
+11K222406Clarius AIClarius Mobile Health Corp.20233—
+11K222191Aixplorer MACH30 / SUPERSONIC MACH30, Aixplorer MACH20 / SUPERSONIC , MACH20, SUPERSONIC…Supersonic Imagine20221—
+11K222365Leltek Ultrasound Imaging System (Model: LU700 Series)Leltek, Inc.20227—
+11K220490ImaCor Zura Handheld ZHH-010Imacor, Inc.202202
+11K211746Pocket Ultrasound SystemGuangdong Youkey Medical Co., Ltd.20221—
+11K213436Clarius Ultrasound ScannerClarius Mobile Health Corp.20212—
+11K211597EPIQ Series Diagnostic Ultrasound System, Affiniti Series Diagnostic Ultrasound SystemPhilips Medical Systems202117—
+11K211527Exo IrisExo Imaging, Inc.20211—
+11K211232Apache Ultrasound SystemAco Healthcare Co., Ltd.20210—
+11K210053LVivo Software ApplicationDia Imaging Analysis, Ltd.202111—
+11K202074Apache Ultrasound System (Model C62)Compal Electronics, Inc.20200—
+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—
+11K202160Sonosite PX Ultrasound System, Sonosite SII Ultrasound System, Sonosite iViz Ultrasound…FUJIFILM Sonosite, Inc.20200—
+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—
+12K250791ASUS Ultrasound Imaging System (LU800 series)Asustek Computer, Inc.20250—
+12K250670EchoConfidence (USA)Mycardium AI Limited20250—
+12K250226Clarius Median Nerve AIClarius Mobile Health Corp.20250—
+12K242681NUSONO Handheld Ultrasound Scanner (NUSONO-C35); NUSONO Handheld Ultrasound Scanner…Nurodata, Inc.20251—
+12K242359Strain AI (SAI001)Exo, Inc.20240—
+12K242223SuperSonic HepaVuSupersonic Imagine20240—
+12K241161Ultrasound Imaging System (LK128L); Ultrasound Imaging System (LK128LH); Ultrasound…Leltek, Inc.20243—
+12K231930Digital Ultrasonic Diagnostic Imaging System (Model: F6)Guangdong Youkey Medical Co., Ltd.20240—
+12K233788EPIQ Series Diagnostic Ultrasound System, Affiniti Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC2024161
+12K232808Butterfly iQ3 Ultrasound SystemButterfly Network, Inc.20241—
+12K232501AI Platform (AIP001)Exo, Inc.20231—
+12K231509Aco Apache Ultrasound SystemAco Healthcare Co., Ltd.20230—
+12K231764Ultrasound System 1300Bk Medical Aps202301
+12K232704Clarius Ultrasound ScannerClarius Mobile Health Corp.20230—
+12K223422Emory Cardiac Toolbox 4.3Syntermed20230—
+12K222970LVivo IQSDia Imaging Analysis, Ltd.20236—
+12K222441Ultrasound System 2300Bk Medical Aps20221—
+12K222198Exo Iris (El2001)Exo Imaging, Inc.20220—
+12K212376Caas QardiaPie Medical Imaging BV20220—
+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
+12K213544Tomtec-ArenaTomtec Imaging Systems GmbH20226—
+12K213275EchoGo Core (2.0)Ultromics Limited20211—
+12K212466LVivo SeamlessDia Imaging Analysis, Ltd.20211—
+12K200603AAA ModelPhilips Ultrasound, Inc.20200—
+12K200852EchoPAC Software Only, EchoPAC Plug-InGE Medical Systems Ultrasound and Primary Care Diagnostics20203—
+12K182450Vivid S60N, Vivid S70NGE Medical Systems Ultrasound and Primary Care Diagnostics201892
+12K173341Vivid E80, Vivid E90, Vivid E95GE Medical Systems2017203
+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—
+13K261288Handheld Ultrasound ScannerImgfax CO., LTD.20260—