510(k) Report

Devices descending from K014206

667 later devices reach Logiqbook through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+11K240115Resona I8W, Resona I8, Resona I8 Exp, Resona I8S, Resona I8T, Resona IY,Resona I8 Easi…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20240—
+11K231930Digital Ultrasonic Diagnostic Imaging System (Model: F6)Guangdong Youkey Medical Co., Ltd.20240—
+11K233692Voluson Signature 20, Voluson Signature 18GE Medical Systems Ultrasound and Primary Care Diagnostics20240—
+11K233439HD60 Series Ultrasound Diagnostic SystemQingdao Hisense Medical Equipment Co., Ltd.20240—
+11K233788EPIQ Series Diagnostic Ultrasound System, Affiniti Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC2024161
+11K2301796440 MyLabX90Esaote, S.p.A.202341
+11K231509Aco Apache Ultrasound SystemAco Healthcare Co., Ltd.20230—
+11K232704Clarius Ultrasound ScannerClarius Mobile Health Corp.20230—
+11K222928Resona R9/ Resona R9 Exp/ Resona R9 Pro/ Resona R9S/ Nuewa R9/ Nuewa R9 Exp Diagnostic…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20233—
+11K222191Aixplorer MACH30 / SUPERSONIC MACH30, Aixplorer MACH20 / SUPERSONIC , MACH20, SUPERSONIC…Supersonic Imagine20221—
+11K221496Consona N6, Consona N6 Pro, Consona N6 Super, Consona AR, Consona N6S, Consona AE…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20220—
+11K221300Consona N9, Consona N9 Pro, Consona N9 Super, Consona Nova, Consona N9S, Consona NI…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20223—
+11K221599HS40 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20220—
+11K220269HM70 EVO Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20223—
+11K220242TEX20/TEX20 Pro/TEX20S/TEX20T/TEX20 Exp/TEX20 Elite, TEX10/ TEX10…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20221—
+11K220051TE Air Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.20223—
+11K213689Voluson P6, Voluson P8GE Healthcare20220—
+11K212333Aplio i900/i800/i700 Diagnostic Ultrasound System, Software V6.5Canon Medical Systems Corporation202261
+11K211824HERA W9, HERA W10 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20213—
+11K211945V8 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.202113—
+11K211300X-CUBE 90Alpinion Medical Systems Co., Ltd.20213—
+11K211299X-CUBE 70Alpinion Medical Systems Co., Ltd.20213—
+11K211337DC-70/DC-70T/DC-70 Pro/DC-70 Exp/DC-75/DC-78/DC-70S Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.20210—
+11K210959RS85 Diagnostic Ultrasound System, RS80 EVO Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20212—
+11K211216Vivid S60N / Vivid S70NGE Medical Systems Ultrasound and Primary Care Diagnostics202132
+11K210068HS50 Diagnostic Ultrasound System, HS60 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20210—
+11K203114Logiq P10, Logiq P9, Logiq P8GE Medical Systems Ultrasound and Primary Care Diagnostics20211—
+11K201768Voluson E10GE Healthcare20204—
+11K202364Aplio a550, Aplio a450, Aplio a, Diagnostic Ultrasound System, Software V5.1Canon Medical Systems Corporation20201—
+11K201828Voluson SWIFT, Voluson SWIFT+GE Medical Systems Ultrasound and Primary Care Diagnostics202010—
+11K200743Vivid E80/ Vivid E90/ Vivid E95Ge Medical Systems Ultrasound And20207—
+11K200655FibroScan® 630Echosens20200—
+11K192879Acclarix AX8 Diagnostic Ultrasound System / Acclarix LX9 Series Diagnostic Ultrasound…Edan Instruments, Inc.20201—
+11K200158Logiq E10GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC202012—
+11K200119LOGIQ E10sGE Medical Systems Ultrasound and Primary Care Diagnostics20209—
+11K192319HERA W9 Diagnostic Ultrasound System, HERA W10 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201920—
+11K192791Diagnostic Ultrasound SystemEdan Instruments, Inc.20191—
+11K1921576450 Ultrasound systemEsaote, S.p.A.20194—
+11K192159Voluson E6, Voluson E8, Voluson E10GE Healthcare20195—
+11K191115RS85 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201923—
+11K190444HERA I10 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20190—
+11K190186Acclarix AX4 Diagnostic Ultrasound System / Acclarix LX4 Diagnostic Ultrasound SystemEdan Instruments, Inc.20190—
+11K1831916420 Ultrasound SystemEsaote, S.p.A.20180—
+11K180572AIXPLORER MACH Ultrasound Diagnostic Systems Aixplorer Mach 30, Aixplorer Mach 20…Supersonic Imagine201816—
+11K172082S60 Series Digital Color Doppler Ultrasound SystemSonoscape Medical Corp.20175—
+11K170999P50 Series Digital Color Doppler Ultrasound SystemSonoscape Medical Corp.20174—
+11K171000P60 Series Digital Color Doppler Ultrasound SystemSonoscape Medical Corp.20174—
+11K170303E5 Series Digital Color Doppler Ultrasound SystemSonoscape Medical Corp.20170—
+11K163427X3 Exp/X3/X3 Pro/X1 Pro/X1 Digital Color Doppler Ultrasound SystemSonoscape Medical Corp.20170—
+12K261668Venue GoGE Medical Systems Ultrasound and Primary care Diagnostics, LLC20260—
+12K261288Handheld Ultrasound ScannerImgfax CO., LTD.20260—
+12K260844ACUSON Sequoia Diagnostic Ultrasound System;ACUSON Sequoia Select Diagnostic Ultrasound…Siemens Medical Solutions USA, Inc.20260—
+12K253949SonoPort Series Digital Color Doppler Ultrasound System (SonoPort 1, SonoPort 1 Exp…CHISON Medical Technologies Co., Ltd.20260—
+12K252709Wireless Probe Type Ultrasound ScannerXuzhou Yongkang Electronic Science Technology Co., Ltd.20260—
+12K251853Consona N5, Consona N5 Pro, Consona N5 Super, Consona N5 Exp, Consona ER, Consona N5S…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20251—
+12K251192Diagnostic Ultrasound System (MX7); Diagnostic Ultrasound System (MX7T); Diagnostic…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20250—
+12K2432536600 Ultrasound System (MyLabA50); 6600 Ultrasound System (MyLabA70)Esaote, S.p.A.20252—
+12K250020Diagnostic Ultrasound System (Recho R9W); Diagnostic Ultrasound System (Recho R9)…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20250—
+12K2416716450 Ultrasound System (MyLabE80); 6450 Ultrasound System (MyLabE85)Esaote, S.p.A.20252—
+12K250110Diagnostic Ultrasound System (MX6); Diagnostic Ultrasound System (MX6S); Diagnostic…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20250—
+12K243226Ultrasound Imaging System (LU700 Series); Ultrasound Imaging System (128 Series)…Leltek, Inc.20251—
+12K250214Acclarix AX8 Series Diagnostic Ultrasound System (Model: Acclarix AX7, Acclarix AX8…Edan Instruments, Inc.20250—
+12K241949Digital Color Doppler Ultrasound System (P60 Series)Sonoscape Medical Corp.20250—
+12K242231Resona A10S, Resona A20 Pro, Resona A20T, Resona A20S, Resona A20W, Resona A20, Resona…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20241—
+12K240980EPIQ Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC20240—
+12K242223SuperSonic HepaVuSupersonic Imagine20240—
+12K241201TEX20/TEX20 Pro/TEX20S/TEX20T/TEX20 Exp/TEX20 Elite/TEX10/TEX10 Pro/TEX10S/TEX10T/TEX10…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20240—
+12K240850EPIQ Series Diagnostic Ultrasound Systems; Affiniti Series Diagnostic Ultrasound SystemsPhilips Ultrasound, LLC202414—
+12K233112HM70 EVO Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20232—
+12K231685TE Air Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.20232—
+12K230365Sonio DetectSonio20237—
+12K230346Voluson SWIFT; Voluson SWIFT+Ge Medical Systems Ultrasound & Primary Care Diagnostic, LLC20231—
+12K223017Aplio i900/i800/i700 Diagnostic Ultrasound System, Software V7.0Canon Medical Systems Corporation20235—
+12K221093X-Cube 70, X-Cube 90Alpinion Medical Systems Co., Ltd.20220—
+12K220857X-Cube 50, X-Cube 60Alpinion Medical Systems Co., Ltd.20221—
+12K221089P12 Elite Series Digital Color Doppler Ultrasound SystemSonoscape Medical Corp.20220—
+12K221140P20 Elite Series Digital Color Doppler Ultrasound SystemSonoscape Medical Corp.20220—
+12K220619Vivid S60N, Vivid S70NGE Medical Systems Ultrasound and Primary Care Diagnostics202222
+12K220975V8 Diagnostic Ultrasound System, V7 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.202212—
+12K221117RS85 Diagnostic Ultrasound System, RS80 EVO Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20221—
+12K220358Voluson Expert 22, Voluson Expert 20, Voluson Expert 18GE Medical Systems Ultrasound and Primary Care Diagnostics20223—
+12K220043HERA W10 Diagnostic Ultrasound System, HERA W9 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20222—
+12K212960Aplio a550, Aplio a450, and Aplio a, Diagnostic Ultrasound System, Software V6.5Canon Medical Systems Corporation202201
+12K214039Logiq P10, Logiq P9, Logiq P8GE Medical Systems Ultrasound and Primary Care Diagnostics202203
+12K2120216430 MyLabX75, 6430 MyLab XPro75Esaote, S.p.A.20210—
+12K211488Logiq E10GE Healthcare202111—
+12K211524LOGIQ E10s, LOGIQ FortisGE Healthcare20218—
+12K202658Vivid E80/ Vivid E90/ Vivid E95GE Medical Systems Ultrasound and Primary Care Diagnostics20215—
+12K202856Diagnostic Ultrasound System, Models: Acclarix AX3, Acclarix AX3 Exp, Acclarix AX3…Edan Instruments, Inc.20210—
+12K201059S60 Elite Series/S70 Series Digital Color Doppler Ultrasound SystemSonoscape Medical Corp.20204—
+12K192030RS80 EVO Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20190—
+12K172993P20 Series Digital Color Doppler Ultrasound SystemSonoscape Medical Corp.20171—
+12K173058P10 Series Digital Color Doppler Ultrasound SystemSonoscape Medical Corp.20171—
+13K260846Diagnostic Ultrasound System (MU9);Diagnostic Ultrasound System (MU9S);Diagnostic…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20260—
+13K261132Healium Intelliscan LX192LCHealium Intelliscan Corporation20260—
+13K2532886450 Ultrasound System (MyLabE80); 6450 Ultrasound System (MyLabE85)Esaote, S.p.A.20260—
+13K254099EVO Q30 Diagnostic Ultrasound System; EVO Q20 Diagnostic Ultrasound System; EVO Q10…Samsung Medison Co., Ltd.20261—
+13K253049Resona A10S, Resona A20 Pro, Resona A20T, Resona A20S, Resona A20W, Resona A20, Resona…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20260—
+13K2533107600 Ultrasound System (MyLabC25); 7600 Ultrasound System (MyLabC30)Esaote, S.p.A.20250—
+13K251455EPIQ Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC20250—