510(k) Report

Devices descending from K122327

365 later devices reach Voluson E6/E8/E8EXPERT/E10 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+8K250020Diagnostic Ultrasound System (Recho R9W); Diagnostic Ultrasound System (Recho R9)…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20250—
+8K250214Acclarix AX8 Series Diagnostic Ultrasound System (Model: Acclarix AX7, Acclarix AX8…Edan Instruments, Inc.20250—
+8K242168Voluson Expert 18; Voluson Expert 20; Voluson Expert 22GE Medical Systems Ultrasound and Primary Care Diagnostics20241—
+8K242444HERA W10 Diagnostic Ultrasound System; HERA W9 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20240—
+8K242231Resona A10S, Resona A20 Pro, Resona A20T, Resona A20S, Resona A20W, Resona A20, Resona…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20241—
+8K241201TEX20/TEX20 Pro/TEX20S/TEX20T/TEX20 Exp/TEX20 Elite/TEX10/TEX10 Pro/TEX10S/TEX10T/TEX10…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20240—
+8K233955Clarius OB AIClarius Mobile Health Corp.20240—
+8K240053Venue GoGE Medical Systems Ultrasound and Primary Care Diagnostics202421
+8K240206Venue SprintGE Medical Systems Ultrasound and Primary Care Diagnostics20242—
+8K234106Venue FitGE Medical Systems Ultrasound and Primary Care Diagnostics202421
+8K233841HD80 Series Ultrasound Diagnostic SystemQingdao Hisense Medical Equipment Co., Ltd.20240—
+8K232908Color Doppler Ultrasound Diagnostic System (CMS1700B), Color Doppler Ultrasound…Contec Medical Systems Co.,Ltd20240—
+8K240406Sonio DetectSonio20244—
+8K233439HD60 Series Ultrasound Diagnostic SystemQingdao Hisense Medical Equipment Co., Ltd.20240—
+8K233112HM70 EVO Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20232—
+8K232381LOGIQ TotusGE Medical Systems Ultrasound and Primary Care Diagnostics20231—
+8K231966Logiq E10GE Medical Systems Ultrasound and Primary Care Diagnostics20235—
+8K231989LOGIQ E10s, LOGIQ FortisGe Medical Systems Ultrasound and Primary Care Diagnostic,20235—
+8K231965Voluson Expert 22, Voluson Expert 20, Voluson Expert 18GE Medical Systems Ultrasound and Primary Care Diagnostics20232—
+8K231772V8/H8 Diagnostic Ultrasound System, V7/H7 Diagnostic Ultrasound System, V6/H6 Diagnostic…Samsung Medison Co., Ltd.20238—
+8K223564X-Cube 50, X-Cube 60Alpinion Medical Systems Co., Ltd.20230—
+8K223017Aplio i900/i800/i700 Diagnostic Ultrasound System, Software V7.0Canon Medical Systems Corporation20235—
+8K223832Vivid S60N, Vivid S70NGe Medical System Ultrasound and Primary Care Diagnostics202312
+8K220882Vivid E80, Vivid E90, Vivid E95Ge Medical Systems Ultrasound And20222—
+8K220051TE Air Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.20223—
+8K211337DC-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—
+8K202856Diagnostic Ultrasound System, Models: Acclarix AX3, Acclarix AX3 Exp, Acclarix AX3…Edan Instruments, Inc.20210—
+8K203114Logiq P10, Logiq P9, Logiq P8GE Medical Systems Ultrasound and Primary Care Diagnostics20211—
+9K261313Vivid Explorer/Vivid Advanced/Vivid FocusGE Medical Systems Ultrasound and Primary Care Diagnostics20260—
+9K261668Venue GoGE Medical Systems Ultrasound and Primary care Diagnostics, LLC20260—
+9K253720uSONIQUE Nova, uSONIQUE Nova Elite, uSONIQUE Vita, uSONIQUE Vita Elite, uSONIQUE Grace…Wuhan United Imaging Healthcare Co.,Ltd20260—
+9K253716uSONIQUE Genesis, uSONIQUE Genesis Pro, uSONIQUE Genesis Elite, uSONIQUE Genesis Super…Wuhan United Imaging Healthcare Co.,Ltd20260—
+9K254099EVO Q30 Diagnostic Ultrasound System; EVO Q20 Diagnostic Ultrasound System; EVO Q10…Samsung Medison Co., Ltd.20261—
+9K252433Sonio Detect (v3)Sonio20260—
+9K253049Resona A10S, Resona A20 Pro, Resona A20T, Resona A20S, Resona A20W, Resona A20, Resona…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20260—
+9K253370LOGIQ TotusGE Medical Systems Ultrasound and Primary Care Diagnostics20260—
+9K253366LOGIQ FortisGE Medical Systems Ultrasound and Primary Care Diagnostics20262—
+9K250959BioticsAIBioticsai, Inc.20250—
+9K252328Voluson Expert 18; Voluson Expert 20; Voluson Expert 22GE Medical Systems Ultrasound and Primary Care Diagnostics20250—
+9K251985Logiq E10GE Medical Systems Ultrasound and Primary Care Diagnostics20250—
+9K251963LOGIQ E10sGE Medical Systems Ultrasound and Primary Care Diagnostics20250—
+9K251169Vivid PioneerGE Medical Systems Ultrasound and Primary Care Diagnostics20250—
+9K240676ULTIMUS Series Ultrasound Diagnostic SystemVinno Technology (Suzhou) Co.,Ltd20240—
+9K241029SpineUs™ SystemVerdure Imaging20240—
+9K241582Aplio i900/i800/i700 Diagnostic Ultrasound System, Software V7.0 (TUS-AI900, TUS-AI800…Canon Medical Systems Corporation20240—
+9K241380Fetoly-HeartDiagnoly20241—
+9K240631V8/XV8/XH8, V7/XV7/XH7, V6/XV6/XH6 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20247—
+9K233195Aplio i900, Aplio i800 and Aplio i700 Software V8.1 Diagnostic Ultrasound SystemCanon Medical Systems Corporation20243—
+9K231685TE Air Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.20232—
+9K214039Logiq P10, Logiq P9, Logiq P8GE Medical Systems Ultrasound and Primary Care Diagnostics202203
+10K263182EVO X30 Diagnostic Ultrasound System; EVO X20 Diagnostic Ultrasound System; EVO X10…Samsung Medison Co., Ltd.20260—
+10K261835LOGIQ FocusGE Medical Systems Ultrasound and Primary Care Diagnostics20260—
+10K260673LOGIQ Vita; LOGIQ Vita Pro; LOGIQ Vita Express; LOGIQ Vita Plus; LOGIQ Vita Power; LOGIQ…GE Medical Systems Ultrasound and Primary Care Diagnostics20260—
+10K251368FetolyDiagnoly20250—
+10K242808Aplio i900/i800/i700 Diagnostic Ultrasound System, Software V8.5Canon Medical Systems Corporation20252—
+10K243702V8 Diagnostic Ultrasound System; cV8 Diagnostic Ultrasound System; V7 Diagnostic…Samsung Medison Co., Ltd.20254—
+10K242511V5 Diagnostic Ultrasound System, H5 Diagnostic Ultrasound System, XV5 Diagnostic…Samsung Medison Co., Ltd.20240—
+10K241971HERA Z20, R20, HERA Z30, R30 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20241—
+10K240906TE Air Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.20241—
+11K253597Aplio beyond and Aplio me Software V2.0 Diagnostic Ultrasound SystemCanon Medical Systems Corporation20260—
+11K252018HERA Z20 Diagnostic Ultrasound System; HERA Z20e Diagnostic Ultrasound System; HERA Z20s…Samsung Medison Co., Ltd.20260—
+11K252074Aplio i900, Aplio i800 and Aplio i700 Software V9.0 Diagnostic Ultrasound SystemCanon Medical Systems Corporation20250—
+11K250999V8 Diagnostic Ultrasound System; cV8 Diagnostic Ultrasound System; V7 Diagnostic…Samsung Medison Co., Ltd.20252—
+11K250024TE Air Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.20250—
+12K261412V8/XV8/XH8/H8/cV8/V8 ONE/XV8 ONE/XH8 ONE/H8 ONE/cV8 ONE Diagnostic Ultrasound System…Samsung Medison Co., Ltd.20261—