510(k) Report

Devices descending from K001400

982 later devices reach Elegra Millennium Enhanced Diagnostic Ultrasound System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+10K240769LVivo IQSDia Imaging Analysis, Ltd.20240—
+10K231930Digital Ultrasonic Diagnostic Imaging System (Model: F6)Guangdong Youkey Medical Co., Ltd.20240—
+10K233788EPIQ Series Diagnostic Ultrasound System, Affiniti Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC2024161
+10K233401Portable Liver Elastography Ultrasound Diagnostic System (Liverscan Mobile)Eieling Technology Limited20242—
+10K232808Butterfly iQ3 Ultrasound SystemButterfly Network, Inc.20241—
+10K231941ARIETTA x10FUJIFILM Healthcare Americas Corporation20230—
+10K231509Aco Apache Ultrasound SystemAco Healthcare Co., Ltd.20230—
+10K230209Sonix HealthOntact Health Co., Ltd.20233—
+10K232704Clarius Ultrasound ScannerClarius Mobile Health Corp.20230—
+10K232336ES Series V2E-Scopics20232—
+10K232459VelacurSonic Incytes20232—
+10K223017Aplio i900/i800/i700 Diagnostic Ultrasound System, Software V7.0Canon Medical Systems Corporation20235—
+10K222198Exo Iris (El2001)Exo Imaging, Inc.20220—
+10K221093X-Cube 70, X-Cube 90Alpinion Medical Systems Co., Ltd.20220—
+10K220857X-Cube 50, X-Cube 60Alpinion Medical Systems Co., Ltd.20221—
+10K220975V8 Diagnostic Ultrasound System, V7 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.202212—
+10K221117RS85 Diagnostic Ultrasound System, RS80 EVO Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20221—
+10K220043HERA W10 Diagnostic Ultrasound System, HERA W9 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20222—
+10K220051TE Air Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.20223—
+10K212704Philips EPIQ Diagnostic Ultrasound System, Philips Affiniti Diagnostic Ultrasound SystemPhilips Medical Systems20212—
+10K210713HM70 EVO Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20214—
+10K210426HS40 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20211—
+10K201965SonoEye P1/ SonoEye P1-G/ SonoEye V1/ SonoEye V1-G/ SonoEye G1/ SonoEye G1-G Digital…CHISON Medical Technologies Co., Ltd.20210—
+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
+10K203114Logiq P10, Logiq P9, Logiq P8GE Medical Systems Ultrasound and Primary Care Diagnostics20211—
+10K202422Arietta 65Hitachi Healthcare Americas20200—
+10K202556HS30 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20200—
+10K201768Voluson E10GE Healthcare20204—
+10K202364Aplio a550, Aplio a450, Aplio a, Diagnostic Ultrasound System, Software V5.1Canon Medical Systems Corporation20201—
+10K200497Vivid S60N, Vivid S70NGE Medical Systems Ultrasound and Primary Care Diagnostics202042
+10K200585Acuson SC2000 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.20208—
+10K200158Logiq E10GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC202012—
+10K200119LOGIQ E10sGE Medical Systems Ultrasound and Primary Care Diagnostics20209—
+10K192159Voluson E6, Voluson E8, Voluson E10GE Healthcare20195—
+10K191233Arietta 750Hitachi Healthcare Americas201901
+10K190248Arietta 50Hitachi Healthcare Americas20191—
+10K181685Vivid E80, Vivid E90, Vivid E95GE Medical Systems Ultrasound and Primary Care Diagnostics201813—
+10K180408U60 Diagnostic Ultrasound SystemEdan Instruments, Inc.20180—
+10K180374Voluson S8/ Voluson S10/ Voluson S10 ExpertGE Healthcare201821
+10K171594AccuroRivanna Medical, LLC20173—
+10K172082S60 Series Digital Color Doppler Ultrasound SystemSonoscape Medical Corp.20175—
+10K170999P50 Series Digital Color Doppler Ultrasound SystemSonoscape Medical Corp.20174—
+10K171000P60 Series Digital Color Doppler Ultrasound SystemSonoscape Medical Corp.20174—
+10K161224LOGIQ V5 Expert, LOGIQ V5, LOGIQ V3GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC201611—
+10K160162Voluson P6, Voluson P8GE Healthcare201613—
+10K142472Voluson E6 / Voluson E8 / Voluson E10 Diagnostic Ultrasound SystemsGE Healthcare2015187—
+10K133277XARIO 100Toshibamedical Systems Corporation20142—
+11K262390BoneXpertVisiana20260—
+11K261623EchoPAC Software Only / EchoPAC Plug-in (v211)GE Medical Systems Ultrasound and Primary Care Diagnostics20260—
+11K261288Handheld Ultrasound ScannerImgfax CO., LTD.20260—
+11K261081Pocket Ultrasound System (C10MTpro,C10MXpro,C10MSpro,C10MBpro,C10MRpro)Beijing Konted Medical Technology Co.,Ltd20260—
+11K260846Diagnostic Ultrasound System (MU9);Diagnostic Ultrasound System (MU9S);Diagnostic…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20260—
+11K260589ES-SeriesE-Scopics20260—
+11K252709Wireless Probe Type Ultrasound ScannerXuzhou Yongkang Electronic Science Technology Co., Ltd.20260—
+11K252148Butterfly Gestational Age ToolButterfly Network, Inc.20260—
+11K260217AI Platform 2.2 (AIP002)Exo Imaging20260—
+11K253221Liver fat ultrasound quantitative system, The FattaLab (FL-CC M1, FL-CC M1_Pro)Eieling Technology (Shenzhen) Limited20260—
+11K251268Diagnostic Ultrasound System (Nano C5, Nano C5 EXP, Nano L12, and Nano L12 EXP)Edan Instruments, Inc.20250—
+11K250914MediAI-BACrescom Co., Ltd.20250—
+11K251322Venue; Venue Go; Venue Fit; Venue SprintGE Medical Systems Ultrasound and Primary Care Diagnostics20251—
+11K243937Accuro 3SRivanna Medical, Inc.20252—
+11K243226Ultrasound Imaging System (LU700 Series); Ultrasound Imaging System (128 Series)…Leltek, Inc.20251—
+11K243684BrightHeart View ClassifierBrightheart20251—
+11K243862LVivo Software ApplicationDia Imaging Analysis, Ltd.20250—
+11K243235LVivo Software ApplicationDia Imaging Analysis, Ltd.20250—
+11K241949Digital Color Doppler Ultrasound System (P60 Series)Sonoscape Medical Corp.20250—
+11K240645Sonix HealthOntact Health Co., Ltd.20240—
+11K242496Portable Liver Elastography Ultrasound Diagnostic System (Liverscan C)Eieling Technology (Shenzhen) Limited20240—
+11K242523ACUSON Sequoia Diagnostic Ultrasound System; ACUSON Sequoia Select Diagnostic Ultrasound…Siemens Medical Solutions USA, Inc.20242—
+11K240980EPIQ Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC20240—
+11K241582Aplio i900/i800/i700 Diagnostic Ultrasound System, Software V7.0 (TUS-AI900, TUS-AI800…Canon Medical Systems Corporation20240—
+11K233977VelacurSonic Incytes20241—
+11K240516RS85 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20240—
+11K240850EPIQ Series Diagnostic Ultrasound Systems; Affiniti Series Diagnostic Ultrasound SystemsPhilips Ultrasound, LLC202414—
+11K231659MS55 Plus Digital Color Doppler Ultrasound System (MS55); P25 Expert Digital Color…Medisono20240—
+11K233195Aplio i900, Aplio i800 and Aplio i700 Software V8.1 Diagnostic Ultrasound SystemCanon Medical Systems Corporation20243—
+11K231685TE Air Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.20232—
+11K231190EPIQ Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC202314
+11K230084HERA W10 Diagnostic Ultrasound System; HERA W9 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20231—
+11K223564X-Cube 50, X-Cube 60Alpinion Medical Systems Co., Ltd.20230—
+11K223387V8 Diagnostic Ultrasound System, V7 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.202311—
+11K221089P12 Elite Series Digital Color Doppler Ultrasound SystemSonoscape Medical Corp.20220—
+11K221140P20 Elite Series Digital Color Doppler Ultrasound SystemSonoscape Medical Corp.20220—
+11K221599HS40 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20220—
+11K220358Voluson Expert 22, Voluson Expert 20, Voluson Expert 18GE Medical Systems Ultrasound and Primary Care Diagnostics20223—
+11K220269HM70 EVO Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20223—
+11K220295Arietta 50Fujifilm Healthcare Corporation20220—
+11K212960Aplio a550, Aplio a450, and Aplio a, Diagnostic Ultrasound System, Software V6.5Canon Medical Systems Corporation202201
+11K214039Logiq P10, Logiq P9, Logiq P8GE Medical Systems Ultrasound and Primary Care Diagnostics202203
+11K213642Voluson S6, Voluson S8, Voluson S8t, Voluson S10, Voluson S10 ExpertGE Healthcare20221—
+11K211488Logiq E10GE Healthcare202111—
+11K211524LOGIQ E10s, LOGIQ FortisGE Healthcare20218—
+11K211216Vivid S60N / Vivid S70NGE Medical Systems Ultrasound and Primary Care Diagnostics202132
+11K201059S60 Elite Series/S70 Series Digital Color Doppler Ultrasound SystemSonoscape Medical Corp.20204—
+11K200743Vivid E80/ Vivid E90/ Vivid E95Ge Medical Systems Ultrasound And20207—
+11K180535Voluson P6 and Voluson P8GE Healthcare2018121