510(k) Report

Devices descending from K003525

1,255 later devices reach Voluson 730 Diagnostic Ultrasound System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+11K240645Sonix HealthOntact Health Co., Ltd.20240—
+11K233977VelacurSonic Incytes20241—
+11K240906TE Air Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.20241—
+11K232381LOGIQ TotusGE Medical Systems Ultrasound and Primary Care Diagnostics20231—
+11K233545EPIQ Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC202301
+11K231966Logiq E10GE Medical Systems Ultrasound and Primary Care Diagnostics20235—
+11K231989LOGIQ E10s, LOGIQ FortisGe Medical Systems Ultrasound and Primary Care Diagnostic,20235—
+11K231965Voluson Expert 22, Voluson Expert 20, Voluson Expert 18GE Medical Systems Ultrasound and Primary Care Diagnostics20232—
+11K231772V8/H8 Diagnostic Ultrasound System, V7/H7 Diagnostic Ultrasound System, V6/H6 Diagnostic…Samsung Medison Co., Ltd.20238—
+11K223832Vivid S60N, Vivid S70NGe Medical System Ultrasound and Primary Care Diagnostics202312
+11K202658Vivid E80/ Vivid E90/ Vivid E95GE Medical Systems Ultrasound and Primary Care Diagnostics20215—
+11K203345MULTIX ImpactSiemens Medical Solutions USA, Inc.20215—
+11K203340MULTIX Impact CSiemens Medical Solutions USA, Inc.20213—
+11K200917Azurion R2.1Philips Medical Systems Nederland B.V.20204Class I
+11K181830Azurion R2.0Philips Medical Systems Nederland B.V.2018542
+12K263182EVO X30 Diagnostic Ultrasound System; EVO X20 Diagnostic Ultrasound System; EVO X10…Samsung Medison Co., Ltd.20260—
+12K261313Vivid Explorer/Vivid Advanced/Vivid FocusGE Medical Systems Ultrasound and Primary Care Diagnostics20260—
+12K262311Alturion Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC20260—
+12K260844ACUSON Sequoia Diagnostic Ultrasound System;ACUSON Sequoia Select Diagnostic Ultrasound…Siemens Medical Solutions USA, Inc.20260—
+12K253720uSONIQUE Nova, uSONIQUE Nova Elite, uSONIQUE Vita, uSONIQUE Vita Elite, uSONIQUE Grace…Wuhan United Imaging Healthcare Co.,Ltd20260—
+12K253716uSONIQUE Genesis, uSONIQUE Genesis Pro, uSONIQUE Genesis Elite, uSONIQUE Genesis Super…Wuhan United Imaging Healthcare Co.,Ltd20260—
+12K253597Aplio beyond and Aplio me Software V2.0 Diagnostic Ultrasound SystemCanon Medical Systems Corporation20260—
+12K253370LOGIQ TotusGE Medical Systems Ultrasound and Primary Care Diagnostics20260—
+12K253366LOGIQ FortisGE Medical Systems Ultrasound and Primary Care Diagnostics20262—
+12K252328Voluson Expert 18; Voluson Expert 20; Voluson Expert 22GE Medical Systems Ultrasound and Primary Care Diagnostics20250—
+12K252074Aplio i900, Aplio i800 and Aplio i700 Software V9.0 Diagnostic Ultrasound SystemCanon Medical Systems Corporation20250—
+12K251985Logiq E10GE Medical Systems Ultrasound and Primary Care Diagnostics20250—
+12K251963LOGIQ E10sGE Medical Systems Ultrasound and Primary Care Diagnostics20250—
+12K251827Azurion R3.1Philips Medical Systems B.V.20251—
+12K251651EPIQ Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC20251—
+12K251728Velacur One (LI-1100)Sonic Incytes Medical Corp20250—
+12K251456BrightHeart View ClassifierBrightheart20250—
+12K250024TE Air Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.20250—
+12K243376uAngio AVIVA CXShanghai United Imaging Healthcare Co., Ltd.20251—
+12K240676ULTIMUS Series Ultrasound Diagnostic SystemVinno Technology (Suzhou) Co.,Ltd20240—
+12K241029SpineUs™ SystemVerdure Imaging20240—
+12K240631V8/XV8/XH8, V7/XV7/XH7, V6/XV6/XH6 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20247—
+12K220882Vivid E80, Vivid E90, Vivid E95Ge Medical Systems Ultrasound And20222—
+12K220919MULTIX Impact ESiemens Medical Solutions USA, Inc.20222—
+12K213700MULTIX Impact, MULTIX Impact CSiemens Medical Solutions USA, Inc.20212—
+13K260488MULTIX Impact; MULTIX Impact CSiemens Medical Solutions USA, Inc.20260—
+13K253726uAngio AVIVA CXShanghai United Imaging Healthcare Co., Ltd.20260—
+13K261835LOGIQ FocusGE Medical Systems Ultrasound and Primary Care Diagnostics20260—
+13K261211Philips EPIQ Series Diagnostic Ultrasound System; Philips Affiniti Series Diagnostic…Philips Ultrasound, LLC20260—
+13K260673LOGIQ Vita; LOGIQ Vita Pro; LOGIQ Vita Express; LOGIQ Vita Plus; LOGIQ Vita Power; LOGIQ…GE Medical Systems Ultrasound and Primary Care Diagnostics20260—
+13K254186Azurion R3.1Philips Medical Systems B.V.20260—
+13K251169Vivid PioneerGE Medical Systems Ultrasound and Primary Care Diagnostics20250—
+13K243702V8 Diagnostic Ultrasound System; cV8 Diagnostic Ultrasound System; V7 Diagnostic…Samsung Medison Co., Ltd.20254—
+13K242499Digital Radiography X-ray System (SONTU100-RAD (E) , SONTU300-Mars (E))Shenzhen Sontu Medical Imaging Equipment Co., Ltd.20250—
+13K242511V5 Diagnostic Ultrasound System, H5 Diagnostic Ultrasound System, XV5 Diagnostic…Samsung Medison Co., Ltd.20240—
+13K241971HERA Z20, R20, HERA Z30, R30 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20241—
+13K233532MULTIX Impact ESiemens Medical Solutions20230—
+14K252018HERA Z20 Diagnostic Ultrasound System; HERA Z20e Diagnostic Ultrasound System; HERA Z20s…Samsung Medison Co., Ltd.20260—
+14K250999V8 Diagnostic Ultrasound System; cV8 Diagnostic Ultrasound System; V7 Diagnostic…Samsung Medison Co., Ltd.20252—
+15K261412V8/XV8/XH8/H8/cV8/V8 ONE/XV8 ONE/XH8 ONE/H8 ONE/cV8 ONE Diagnostic Ultrasound System…Samsung Medison Co., Ltd.20261—