510(k) Report

Devices descending from K082185

627 later devices reach GE Logiq E9 Diagnostic Ultrasound System, Models 5205000, 5205000-2 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+9K241201TEX20/TEX20 Pro/TEX20S/TEX20T/TEX20 Exp/TEX20 Elite/TEX10/TEX10 Pro/TEX10S/TEX10T/TEX10…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20240—
+9K241432MX7/MX7T/Vaus7/Zeus/ME7/Anesus ME7/Anesus ME7T/MX7P/MX7W/MX8/MX8T/Vaus8/ME8 Diagnostic…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20241—
+9K233697SonoMax Series Digital Color Doppler Ultrasound SystemCHISON Medical Technologies Co., Ltd.20241—
+9K240516RS85 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20240—
+9K233841HD80 Series Ultrasound Diagnostic SystemQingdao Hisense Medical Equipment Co., Ltd.20240—
+9K232908Color Doppler Ultrasound Diagnostic System (CMS1700B), Color Doppler Ultrasound…Contec Medical Systems Co.,Ltd20240—
+9K233439HD60 Series Ultrasound Diagnostic SystemQingdao Hisense Medical Equipment Co., Ltd.20240—
+9K233112HM70 EVO Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20232—
+9K232381LOGIQ TotusGE Medical Systems Ultrasound and Primary Care Diagnostics20231—
+9K231966Logiq E10GE Medical Systems Ultrasound and Primary Care Diagnostics20235—
+9K231989LOGIQ E10s, LOGIQ FortisGe Medical Systems Ultrasound and Primary Care Diagnostic,20235—
+9K232617ACUSON Maple Diagnostic Ultrasound System, ACUSON Maple Select Diagnostic Ultrasound…Siemens Medical Solutions USA, Inc.202312
+9K230365Sonio DetectSonio20237—
+9K230346Voluson SWIFT; Voluson SWIFT+Ge Medical Systems Ultrasound & Primary Care Diagnostic, LLC20231—
+9K230084HERA W10 Diagnostic Ultrasound System; HERA W9 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20231—
+9K223017Aplio i900/i800/i700 Diagnostic Ultrasound System, Software V7.0Canon Medical Systems Corporation20235—
+9K223832Vivid S60N, Vivid S70NGe Medical System Ultrasound and Primary Care Diagnostics202312
+9K223387V8 Diagnostic Ultrasound System, V7 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.202311—
+9K223735ACUSON Sequoia Diagnostic Ultrasound System, ACUSON Sequoia Select Diagnostic Ultrasound…Siemens Medical Solutions USA, Inc.20235—
+9K221093X-Cube 70, X-Cube 90Alpinion Medical Systems Co., Ltd.20220—
+9K220857X-Cube 50, X-Cube 60Alpinion Medical Systems Co., Ltd.20221—
+9K221496Consona N6, Consona N6 Pro, Consona N6 Super, Consona AR, Consona N6S, Consona AE…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20220—
+9K221300Consona N9, Consona N9 Pro, Consona N9 Super, Consona Nova, Consona N9S, Consona NI…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20223—
+9K214039Logiq P10, Logiq P9, Logiq P8GE Medical Systems Ultrasound and Primary Care Diagnostics202203
+9K220051TE Air Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.20223—
+9K211337DC-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—
+9K201597Liver Incytes, Model 1005Sonic Incytes20204—
+9K201462ACUSON Sequoia Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.2020241
+9K201062syngo Ultrasound Apps Suite (sUSAS)Siemens Medical Solutions USA, Inc.20200—
+9K200707ACUSON Sequoia Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.202025—
+9K193257ACUSON Sequoia Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.2020261
+9K190646QT Scanner 2000 Model AQt Ultrasound, LLC20192—
+9K183575ACUSON S3000, S2000 Diagnostic Ultrasound SystemSiemens Healthineers201926—
+9K182596Xario200G and Xario100G, Software V1.1 Diagnostic Ultrasound SystemCanon Medical Systems Corporation20182—
+9K180799Clarius Ultrasound ScannerClarius Mobile Health Corp.201811—
+9K180067ACUSON X800 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.201828—
+9K173034FibroScan® Family of Products (Models: 502 Touch, 530 Compact, and 430 Mini+)Echosens201715—
+9K172142FibroScan 430 Mini+Echosens20170—
+9K170315Acuson SC2000 Diagnostic Ultrasound SystemSiemens Medi Cal Solutions, Inc.2017451
+10K261313Vivid Explorer/Vivid Advanced/Vivid FocusGE Medical Systems Ultrasound and Primary Care Diagnostics20260—
+10K261668Venue GoGE Medical Systems Ultrasound and Primary care Diagnostics, LLC20260—
+10K260748ES-SeriesE-Scopics20260—
+10K253949SonoPort Series Digital Color Doppler Ultrasound System (SonoPort 1, SonoPort 1 Exp…CHISON Medical Technologies Co., Ltd.20260—
+10K253720uSONIQUE Nova, uSONIQUE Nova Elite, uSONIQUE Vita, uSONIQUE Vita Elite, uSONIQUE Grace…Wuhan United Imaging Healthcare Co.,Ltd20260—
+10K253716uSONIQUE Genesis, uSONIQUE Genesis Pro, uSONIQUE Genesis Elite, uSONIQUE Genesis Super…Wuhan United Imaging Healthcare Co.,Ltd20260—
+10K254099EVO Q30 Diagnostic Ultrasound System; EVO Q20 Diagnostic Ultrasound System; EVO Q10…Samsung Medison Co., Ltd.20261—
+10K253049Resona A10S, Resona A20 Pro, Resona A20T, Resona A20S, Resona A20W, Resona A20, Resona…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20260—
+10K253370LOGIQ TotusGE Medical Systems Ultrasound and Primary Care Diagnostics20260—
+10K253366LOGIQ FortisGE Medical Systems Ultrasound and Primary Care Diagnostics20262—
+10K253487ACUSON Maple Diagnostic Ultrasound System; ACUSON Maple Select Diagnostic Ultrasound…Siemens Medical Solutions USA, Inc.20250—
+10K251853Consona N5, Consona N5 Pro, Consona N5 Super, Consona N5 Exp, Consona ER, Consona N5S…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20251—
+10K251985Logiq E10GE Medical Systems Ultrasound and Primary Care Diagnostics20250—
+10K251963LOGIQ E10sGE Medical Systems Ultrasound and Primary Care Diagnostics20250—
+10K251192Diagnostic Ultrasound System (MX7); Diagnostic Ultrasound System (MX7T); Diagnostic…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20250—
+10K250543Voluson™ Performance 16; Voluson™ Performance 18GE Medical Systems Ultrasound and Primary Care Diagnostics20250—
+10K242594DeepechoDeepecho20250—
+10K250110Diagnostic Ultrasound System (MX6); Diagnostic Ultrasound System (MX6S); Diagnostic…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20250—
+10K240676ULTIMUS Series Ultrasound Diagnostic SystemVinno Technology (Suzhou) Co.,Ltd20240—
+10K242444HERA W10 Diagnostic Ultrasound System; HERA W9 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20240—
+10K241029SpineUs™ SystemVerdure Imaging20240—
+10K241582Aplio i900/i800/i700 Diagnostic Ultrasound System, Software V7.0 (TUS-AI900, TUS-AI800…Canon Medical Systems Corporation20240—
+10K233955Clarius OB AIClarius Mobile Health Corp.20240—
+10K240406Sonio DetectSonio20244—
+10K233195Aplio i900, Aplio i800 and Aplio i700 Software V8.1 Diagnostic Ultrasound SystemCanon Medical Systems Corporation20243—
+10K232988Aplio flex and Aplio go Software V2.0 Diagnostic Ultrasound SystemCanon Medical Systems Corporation20230—
+10K232145ACUSON Sequoia Diagnostic Ultrasound System, ACUSON Sequoia Select Diagnostic Ultrasound…Siemens Medical Solutions USA, Inc.20234—
+10K231685TE Air Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.20232—
+10K231772V8/H8 Diagnostic Ultrasound System, V7/H7 Diagnostic Ultrasound System, V6/H6 Diagnostic…Samsung Medison Co., Ltd.20238—
+10K223287VelacurSonic Incytes20233—
+10K223564X-Cube 50, X-Cube 60Alpinion Medical Systems Co., Ltd.20230—
+10K220933QT Scanner 2000 Model AQt Imaging, Inc.20221—
+10K211859ACUSON Sequoia Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.202171
+10K192107Clarius Ultrasound ScannerClarius Mobile Health Corp.201910—
+10K181547FibroScan® Family of Products (Models: 502 Touch, 530 Compact, and 430 Mini+)Echosens201814—
+10K171766Acuson SC2000 Diagnostic Ultrasound SystemSiemens Medi Cal Solutions, Inc.201720—
+11K263182EVO X30 Diagnostic Ultrasound System; EVO X20 Diagnostic Ultrasound System; EVO X10…Samsung Medison Co., Ltd.20260—
+11K261835LOGIQ FocusGE Medical Systems Ultrasound and Primary Care Diagnostics20260—
+11K260846Diagnostic Ultrasound System (MU9);Diagnostic Ultrasound System (MU9S);Diagnostic…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20260—
+11K260673LOGIQ Vita; LOGIQ Vita Pro; LOGIQ Vita Express; LOGIQ Vita Plus; LOGIQ Vita Power; LOGIQ…GE Medical Systems Ultrasound and Primary Care Diagnostics20260—
+11K252433Sonio Detect (v3)Sonio20260—
+11K253898QT Scanner 2000 Model AQT Imaging Holdings, Inc.20260—
+11K250959BioticsAIBioticsai, Inc.20250—
+11K242808Aplio i900/i800/i700 Diagnostic Ultrasound System, Software V8.5Canon Medical Systems Corporation20252—
+11K241380Fetoly-HeartDiagnoly20241—
+11K240906TE Air Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.20241—
+11K240704ACUSON Sequoia Diagnostic Ultrasound System, ACUSON Sequoia Select Diagnostic Ultrasound…Siemens Medical Solutions USA, Inc.20243—
+11K240631V8/XV8/XH8, V7/XV7/XH7, V6/XV6/XH6 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20247—
+11K232459VelacurSonic Incytes20232—
+11K211665SONON Ultrasound Imaging System, Model: SONON300CHealcerion Co., Ltd.20220—
+11K212400SONON Ultrasound Imaging System, Model: SONON 500LHealcerion Co., Ltd.20220—
+11K220490ImaCor Zura Handheld ZHH-010Imacor, Inc.202202
+11K211746Pocket Ultrasound SystemGuangdong Youkey Medical Co., Ltd.20221—
+11K213436Clarius Ultrasound ScannerClarius Mobile Health Corp.20212—
+11K211232Apache Ultrasound SystemAco Healthcare Co., Ltd.20210—
+11K203273FibroScan® Family of Products (Models: 502 Touch, 530 Compact, 430 Mini+, and 630)Echosens20219—
+11K202074Apache Ultrasound System (Model C62)Compal Electronics, Inc.20200—
+11K200136Shear Wave Quantificational Ultrasound Diagnostic SystemWuxi Hisky Medical Technologies Co., Ltd.20202—
+11K181098ACUSON SC2000 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.201819—
+12K253597Aplio beyond and Aplio me Software V2.0 Diagnostic Ultrasound SystemCanon Medical Systems Corporation20260—
+12K252074Aplio i900, Aplio i800 and Aplio i700 Software V9.0 Diagnostic Ultrasound SystemCanon Medical Systems Corporation20250—