510(k) Report

Devices descending from K061215

613 later devices reach Volcano S51 Family of Imaging Systems through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+10K221300Consona N9, Consona N9 Pro, Consona N9 Super, Consona Nova, Consona N9S, Consona NI…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20223—
+10K221599HS40 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20220—
+10K220882Vivid E80, Vivid E90, Vivid E95Ge Medical Systems Ultrasound And20222—
+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—
+10K220269HM70 EVO Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20223—
+10K220043HERA W10 Diagnostic Ultrasound System, HERA W9 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20222—
+10K214039Logiq P10, Logiq P9, Logiq P8GE Medical Systems Ultrasound and Primary Care Diagnostics202203
+10K220051TE Air Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.20223—
+10K211859ACUSON Sequoia Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.202171
+10K211337DC-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—
+10K201597Liver Incytes, Model 1005Sonic Incytes20204—
+10K192879Acclarix AX8 Diagnostic Ultrasound System / Acclarix LX9 Series Diagnostic Ultrasound…Edan Instruments, Inc.20201—
+10K201062syngo Ultrasound Apps Suite (sUSAS)Siemens Medical Solutions USA, Inc.20200—
+10K192791Diagnostic Ultrasound SystemEdan Instruments, Inc.20191—
+10K190646QT Scanner 2000 Model AQt Ultrasound, LLC20192—
+10K192107Clarius Ultrasound ScannerClarius Mobile Health Corp.201910—
+10K190186Acclarix AX4 Diagnostic Ultrasound System / Acclarix LX4 Diagnostic Ultrasound SystemEdan Instruments, Inc.20190—
+10K182596Xario200G and Xario100G, Software V1.1 Diagnostic Ultrasound SystemCanon Medical Systems Corporation20182—
+10K173034FibroScan® Family of Products (Models: 502 Touch, 530 Compact, and 430 Mini+)Echosens201715—
+10K172142FibroScan 430 Mini+Echosens20170—
+10K170315Acuson SC2000 Diagnostic Ultrasound SystemSiemens Medi Cal Solutions, Inc.2017451
+11K261313Vivid Explorer/Vivid Advanced/Vivid FocusGE Medical Systems Ultrasound and Primary Care Diagnostics20260—
+11K261668Venue GoGE Medical Systems Ultrasound and Primary care Diagnostics, LLC20260—
+11K253949SonoPort Series Digital Color Doppler Ultrasound System (SonoPort 1, SonoPort 1 Exp…CHISON Medical Technologies Co., Ltd.20260—
+11K253720uSONIQUE Nova, uSONIQUE Nova Elite, uSONIQUE Vita, uSONIQUE Vita Elite, uSONIQUE Grace…Wuhan United Imaging Healthcare Co.,Ltd20260—
+11K253716uSONIQUE Genesis, uSONIQUE Genesis Pro, uSONIQUE Genesis Elite, uSONIQUE Genesis Super…Wuhan United Imaging Healthcare Co.,Ltd20260—
+11K253049Resona A10S, Resona A20 Pro, Resona A20T, Resona A20S, Resona A20W, Resona A20, Resona…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20260—
+11K253370LOGIQ TotusGE Medical Systems Ultrasound and Primary Care Diagnostics20260—
+11K253366LOGIQ FortisGE Medical Systems Ultrasound and Primary Care Diagnostics20262—
+11K252328Voluson Expert 18; Voluson Expert 20; Voluson Expert 22GE Medical Systems Ultrasound and Primary Care Diagnostics20250—
+11K251853Consona N5, Consona N5 Pro, Consona N5 Super, Consona N5 Exp, Consona ER, Consona N5S…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20251—
+11K251985Logiq E10GE Medical Systems Ultrasound and Primary Care Diagnostics20250—
+11K251963LOGIQ E10sGE Medical Systems Ultrasound and Primary Care Diagnostics20250—
+11K251192Diagnostic Ultrasound System (MX7); Diagnostic Ultrasound System (MX7T); Diagnostic…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20250—
+11K251169Vivid PioneerGE Medical Systems Ultrasound and Primary Care Diagnostics20250—
+11K250543Voluson™ Performance 16; Voluson™ Performance 18GE Medical Systems Ultrasound and Primary Care Diagnostics20250—
+11K242594DeepechoDeepecho20250—
+11K250110Diagnostic Ultrasound System (MX6); Diagnostic Ultrasound System (MX6S); Diagnostic…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20250—
+11K250214Acclarix AX8 Series Diagnostic Ultrasound System (Model: Acclarix AX7, Acclarix AX8…Edan Instruments, Inc.20250—
+11K240676ULTIMUS Series Ultrasound Diagnostic SystemVinno Technology (Suzhou) Co.,Ltd20240—
+11K241029SpineUs™ SystemVerdure Imaging20240—
+11K241582Aplio i900/i800/i700 Diagnostic Ultrasound System, Software V7.0 (TUS-AI900, TUS-AI800…Canon Medical Systems Corporation20240—
+11K240704ACUSON Sequoia Diagnostic Ultrasound System, ACUSON Sequoia Select Diagnostic Ultrasound…Siemens Medical Solutions USA, Inc.20243—
+11K233955Clarius OB AIClarius Mobile Health Corp.20240—
+11K240516RS85 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20240—
+11K240406Sonio DetectSonio20244—
+11K233195Aplio i900, Aplio i800 and Aplio i700 Software V8.1 Diagnostic Ultrasound SystemCanon Medical Systems Corporation20243—
+11K233112HM70 EVO Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20232—
+11K232988Aplio flex and Aplio go Software V2.0 Diagnostic Ultrasound SystemCanon Medical Systems Corporation20230—
+11K231685TE Air Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.20232—
+11K230084HERA W10 Diagnostic Ultrasound System; HERA W9 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20231—
+11K223287VelacurSonic Incytes20233—
+11K223564X-Cube 50, X-Cube 60Alpinion Medical Systems Co., Ltd.20230—
+11K223387V8 Diagnostic Ultrasound System, V7 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.202311—
+11K220933QT Scanner 2000 Model AQt Imaging, Inc.20221—
+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—
+11K202856Diagnostic Ultrasound System, Models: Acclarix AX3, Acclarix AX3 Exp, Acclarix AX3…Edan Instruments, Inc.20210—
+11K202074Apache Ultrasound System (Model C62)Compal Electronics, Inc.20200—
+11K181547FibroScan® Family of Products (Models: 502 Touch, 530 Compact, and 430 Mini+)Echosens201814—
+11K171766Acuson SC2000 Diagnostic Ultrasound SystemSiemens Medi Cal Solutions, Inc.201720—
+12K261835LOGIQ FocusGE Medical Systems Ultrasound and Primary Care Diagnostics20260—
+12K260846Diagnostic Ultrasound System (MU9);Diagnostic Ultrasound System (MU9S);Diagnostic…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20260—
+12K254099EVO Q30 Diagnostic Ultrasound System; EVO Q20 Diagnostic Ultrasound System; EVO Q10…Samsung Medison Co., Ltd.20261—
+12K260673LOGIQ Vita; LOGIQ Vita Pro; LOGIQ Vita Express; LOGIQ Vita Plus; LOGIQ Vita Power; LOGIQ…GE Medical Systems Ultrasound and Primary Care Diagnostics20260—
+12K252433Sonio Detect (v3)Sonio20260—
+12K253898QT Scanner 2000 Model AQT Imaging Holdings, Inc.20260—
+12K250959BioticsAIBioticsai, Inc.20250—
+12K242808Aplio i900/i800/i700 Diagnostic Ultrasound System, Software V8.5Canon Medical Systems Corporation20252—
+12K242444HERA W10 Diagnostic Ultrasound System; HERA W9 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20240—
+12K242523ACUSON Sequoia Diagnostic Ultrasound System; ACUSON Sequoia Select Diagnostic Ultrasound…Siemens Medical Solutions USA, Inc.20242—
+12K241380Fetoly-HeartDiagnoly20241—
+12K240906TE Air Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.20241—
+12K231930Digital Ultrasonic Diagnostic Imaging System (Model: F6)Guangdong Youkey Medical Co., Ltd.20240—
+12K231509Aco Apache Ultrasound SystemAco Healthcare Co., Ltd.20230—
+12K232704Clarius Ultrasound ScannerClarius Mobile Health Corp.20230—
+12K231772V8/H8 Diagnostic Ultrasound System, V7/H7 Diagnostic Ultrasound System, V6/H6 Diagnostic…Samsung Medison Co., Ltd.20238—
+12K232459VelacurSonic Incytes20232—
+12K203273FibroScan® Family of Products (Models: 502 Touch, 530 Compact, 430 Mini+, and 630)Echosens20219—
+12K200136Shear Wave Quantificational Ultrasound Diagnostic SystemWuxi Hisky Medical Technologies Co., Ltd.20202—
+12K181098ACUSON SC2000 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.201819—
+13K263182EVO X30 Diagnostic Ultrasound System; EVO X20 Diagnostic Ultrasound System; EVO X10…Samsung Medison Co., Ltd.20260—
+13K253597Aplio beyond and Aplio me Software V2.0 Diagnostic Ultrasound SystemCanon Medical Systems Corporation20260—
+13K252074Aplio i900, Aplio i800 and Aplio i700 Software V9.0 Diagnostic Ultrasound SystemCanon Medical Systems Corporation20250—
+13K250026Shear Wave Quantificational Ultrasound Diagnostic System…Wuxi Hisky Medical Technologies Co., Ltd.20250—
+13K251368FetolyDiagnoly20250—
+13K251481ACUSON Sequoia Diagnostic Ultrasound System; ACUSON Sequoia Select Diagnostic Ultrasound…Siemens Medical Solutions USA, Inc.20251—
+13K243880Shear Wave Quantificational Ultrasound Diagnostic System (Mini900, Mini990, Mini800…Wuxi Hisky Medical Technologies Co., Ltd.20250—
+13K250024TE Air Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.20250—
+13K233977VelacurSonic Incytes20241—
+13K240631V8/XV8/XH8, V7/XV7/XH7, V6/XV6/XH6 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20247—
+13K223902FibroScan® device (Models: 502 Touch, 530 Compact, 430 Mini+, 230, and 630)Echosens20231—
+13K213102ES1 SystemE-Scopics20223—
+13K212035FibroScan 230Echosens20215—
+13K200585Acuson SC2000 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.20208—