510(k) Report

Devices descending from K934139

1,289 later devices reach Tomtec Echo-View through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+13K1827504D ViewGE Medical Systems Ultrasound and Primary Care Diagnostics20180—
+13K181376Arietta 65Hitachi Healthcare Americas Corporation201831
+13K172256SoftVueDelphinus Medical Technologies20180—
+13K162372QT Ultrasound Breast Scanner-1Qt Ultrasound, LLC20174—
+13K162155Xario 200 Diagnostic Ultrasound System V5.0Toshibamedical Systems Corporation201641
+13K161047LOGIQ P9 and LOGIQ P7GE Healthcare2016107—
+13K160078Vivid T8Ge Medical Systems Ultrasound and Primary Care Diagnotics, L201618—
+13K160184Voluson S6, Voluson S8, Voluson S10GE Healthcare2016551
+13K153037Logiq V1/ Logiq V2GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC20160—
+13K152758Venue 50GE Medical Systems Ultrasound and Primary Care Diagnostics201555—
+13K143601U-LiteSonoscanner Sarl20153—
+13K143046Xario 100, V3.0Toshibamedical Systems Corporation201411
+13K141768Logiq V5/Logiq V3GE Healthcare201457—
+13K141675Voluson P6, Voluson P8GE Healthcare201414—
+13K141067Vivid T8/Vivid T8 ProGE Healthcare201419—
+13K132913Voluson E6 / E8 / E8EXPERT / E8EXPERT Limited Edition / E10GE Healthcare2013255—
+14K260488MULTIX Impact; MULTIX Impact CSiemens Medical Solutions USA, Inc.20260—
+14K253726uAngio AVIVA CXShanghai United Imaging Healthcare Co., Ltd.20260—
+14K261211Philips EPIQ Series Diagnostic Ultrasound System; Philips Affiniti Series Diagnostic…Philips Ultrasound, LLC20260—
+14K260398LOGIQ eGE Medical Systems Ultrasound and Primary Care Diagnostics20260—
+14K253720uSONIQUE Nova, uSONIQUE Nova Elite, uSONIQUE Vita, uSONIQUE Vita Elite, uSONIQUE Grace…Wuhan United Imaging Healthcare Co.,Ltd20260—
+14K253716uSONIQUE Genesis, uSONIQUE Genesis Pro, uSONIQUE Genesis Elite, uSONIQUE Genesis Super…Wuhan United Imaging Healthcare Co.,Ltd20260—
+14K254186Azurion R3.1Philips Medical Systems B.V.20260—
+14K253370LOGIQ TotusGE Medical Systems Ultrasound and Primary Care Diagnostics20260—
+14K253366LOGIQ FortisGE Medical Systems Ultrasound and Primary Care Diagnostics20262—
+14K252328Voluson Expert 18; Voluson Expert 20; Voluson Expert 22GE Medical Systems Ultrasound and Primary Care Diagnostics20250—
+14K251985Logiq E10GE Medical Systems Ultrasound and Primary Care Diagnostics20250—
+14K251963LOGIQ E10sGE Medical Systems Ultrasound and Primary Care Diagnostics20250—
+14K251322Venue; Venue Go; Venue Fit; Venue SprintGE Medical Systems Ultrasound and Primary Care Diagnostics20251—
+14K251728Velacur One (LI-1100)Sonic Incytes Medical Corp20250—
+14K250024TE Air Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.20250—
+14K241222Ventripoint Medical System Plus (VMS+) 4.0Ventripoint Diagnostics, Ltd.20250—
+14K242499Digital Radiography X-ray System (SONTU100-RAD (E) , SONTU300-Mars (E))Shenzhen Sontu Medical Imaging Equipment Co., Ltd.20250—
+14K240676ULTIMUS Series Ultrasound Diagnostic SystemVinno Technology (Suzhou) Co.,Ltd20240—
+14K241029SpineUs™ SystemVerdure Imaging20240—
+14K240631V8/XV8/XH8, V7/XV7/XH7, V6/XV6/XH6 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20247—
+14K240053Venue GoGE Medical Systems Ultrasound and Primary Care Diagnostics202421
+14K240206Venue SprintGE Medical Systems Ultrasound and Primary Care Diagnostics20242—
+14K234106Venue FitGE Medical Systems Ultrasound and Primary Care Diagnostics202421
+14K233532MULTIX Impact ESiemens Medical Solutions20230—
+14K231941ARIETTA x10FUJIFILM Healthcare Americas Corporation20230—
+14K202422Arietta 65Hitachi Healthcare Americas20200—
+14K191233Arietta 750Hitachi Healthcare Americas201901
+14K190248Arietta 50Hitachi Healthcare Americas20191—
+14K182213QT Ultrasound Breast Scanner - 1Qt Ultrasound, LLC20183—
+14K180374Voluson S8/ Voluson S10/ Voluson S10 ExpertGE Healthcare201821
+14K172276Xario 200 Diagnostic Ultrasound System V6.0Toshibamedical Systems Corporation20173—
+14K171164U-Lite EXPSonoscanner20172—
+14K163596LOGIQ P9 and LOGIQ P7GE Healthcare201747—
+14K162187Xario 100 Diagnostic Ultrasound System, V5.0Toshibamedical Systems Corporation201601
+14K161224LOGIQ V5 Expert, LOGIQ V5, LOGIQ V3GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC201611—
+14K160162Voluson P6, Voluson P8GE Healthcare201613—
+14K142472Voluson E6 / Voluson E8 / Voluson E10 Diagnostic Ultrasound SystemsGE Healthcare2015187—
+15K261668Venue GoGE Medical Systems Ultrasound and Primary care Diagnostics, LLC20260—
+15K261835LOGIQ FocusGE Medical Systems Ultrasound and Primary Care Diagnostics20260—
+15K260673LOGIQ Vita; LOGIQ Vita Pro; LOGIQ Vita Express; LOGIQ Vita Plus; LOGIQ Vita Power; LOGIQ…GE Medical Systems Ultrasound and Primary Care Diagnostics20260—
+15K243702V8 Diagnostic Ultrasound System; cV8 Diagnostic Ultrasound System; V7 Diagnostic…Samsung Medison Co., Ltd.20254—
+15K242511V5 Diagnostic Ultrasound System, H5 Diagnostic Ultrasound System, XV5 Diagnostic…Samsung Medison Co., Ltd.20240—
+15K241971HERA Z20, R20, HERA Z30, R30 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20241—
+15K220295Arietta 50Fujifilm Healthcare Corporation20220—
+15K213642Voluson S6, Voluson S8, Voluson S8t, Voluson S10, Voluson S10 ExpertGE Healthcare20221—
+15K201988T-LiteSonoscanner20201—
+15K190646QT Scanner 2000 Model AQt Ultrasound, LLC20192—
+15K182596Xario200G and Xario100G, Software V1.1 Diagnostic Ultrasound SystemCanon Medical Systems Corporation20182—
+15K181783Logiq P9; Logiq P7GE Healthcare2018171
+15K180535Voluson P6 and Voluson P8GE Healthcare2018121
+15K152567Voluson E6, Voluson E8, Voluson E10 Diagnostic Ultrasound SystemGE Healthcare2015154—
+16K252018HERA Z20 Diagnostic Ultrasound System; HERA Z20e Diagnostic Ultrasound System; HERA Z20s…Samsung Medison Co., Ltd.20260—
+16K250999V8 Diagnostic Ultrasound System; cV8 Diagnostic Ultrasound System; V7 Diagnostic…Samsung Medison Co., Ltd.20252—
+16K233692Voluson Signature 20, Voluson Signature 18GE Medical Systems Ultrasound and Primary Care Diagnostics20240—
+16K232285U-Lite PROSonoscanner Sarl20240—
+16K232988Aplio flex and Aplio go Software V2.0 Diagnostic Ultrasound SystemCanon Medical Systems Corporation20230—
+16K220933QT Scanner 2000 Model AQt Imaging, Inc.20221—
+16K213689Voluson P6, Voluson P8GE Healthcare20220—
+16K203114Logiq P10, Logiq P9, Logiq P8GE Medical Systems Ultrasound and Primary Care Diagnostics20211—
+16K201828Voluson SWIFT, Voluson SWIFT+GE Medical Systems Ultrasound and Primary Care Diagnostics202010—
+17K261412V8/XV8/XH8/H8/cV8/V8 ONE/XV8 ONE/XH8 ONE/H8 ONE/cV8 ONE Diagnostic Ultrasound System…Samsung Medison Co., Ltd.20261—
+17K253898QT Scanner 2000 Model AQT Imaging Holdings, Inc.20260—
+17K230365Sonio DetectSonio20237—
+17K230346Voluson SWIFT; Voluson SWIFT+Ge Medical Systems Ultrasound & Primary Care Diagnostic, LLC20231—
+17K214039Logiq P10, Logiq P9, Logiq P8GE Medical Systems Ultrasound and Primary Care Diagnostics202203
+18K250543Voluson™ Performance 16; Voluson™ Performance 18GE Medical Systems Ultrasound and Primary Care Diagnostics20250—
+18K242594DeepechoDeepecho20250—
+18K233955Clarius OB AIClarius Mobile Health Corp.20240—
+18K240406Sonio DetectSonio20244—
+19K252433Sonio Detect (v3)Sonio20260—
+19K250959BioticsAIBioticsai, Inc.20250—
+19K241380Fetoly-HeartDiagnoly20241—
+20K251368FetolyDiagnoly20250—