510(k) Report

Devices descending from K002470

1,238 later devices reach M2424A Sonos 5500/4500 Diagnostic Ultrasound System, Version B.2. 21330A… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+11K231965Voluson Expert 22, Voluson Expert 20, Voluson Expert 18GE Medical Systems Ultrasound and Primary Care Diagnostics20232—
+11K231685TE Air Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.20232—
+11K232459VelacurSonic Incytes20232—
+11K230084HERA W10 Diagnostic Ultrasound System; HERA W9 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20231—
+11K223832Vivid S60N, Vivid S70NGe Medical System Ultrasound and Primary Care Diagnostics202312
+11K223387V8 Diagnostic Ultrasound System, V7 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.202311—
+11K220882Vivid E80, Vivid E90, Vivid E95Ge Medical Systems Ultrasound And20222—
+11K220851VenueGE Medical Systems20223—
+11K212960Aplio a550, Aplio a450, and Aplio a, Diagnostic Ultrasound System, Software V6.5Canon Medical Systems Corporation202201
+11K210438Versana PremierGE Medical Systems Ultrasound and Primary Care Diagnostics20211—
+11K211488Logiq E10GE Healthcare202111—
+11K211524LOGIQ E10s, LOGIQ FortisGE Healthcare20218—
+11K203345MULTIX ImpactSiemens Medical Solutions USA, Inc.20215—
+11K203340MULTIX Impact CSiemens Medical Solutions USA, Inc.20213—
+11K203137Venue FitGE Medical Systems Ultrasound and Primary Care Diagnostics202051
+11K202233Venue GoGE Medical Systems Ultrasound and Primary Care Diagnostics202042
+11K200917Azurion R2.1Philips Medical Systems Nederland B.V.20204Class I
+11K191493Ventripoint Medical System Plus (VMS+) 3.0Ventripoint Diagnostics, Ltd.20191—
+11K183456Aloka Arietta 850Hitachi Healthcare Americas201923
+11K1827504D ViewGE Medical Systems Ultrasound and Primary Care Diagnostics20180—
+11K181830Azurion R2.0Philips Medical Systems Nederland B.V.2018542
+11K181376Arietta 65Hitachi Healthcare Americas Corporation201831
+11K161047LOGIQ P9 and LOGIQ P7GE Healthcare2016107—
+11K160078Vivid T8Ge Medical Systems Ultrasound and Primary Care Diagnotics, L201618—
+11K160184Voluson S6, Voluson S8, Voluson S10GE Healthcare2016551
+11K153037Logiq V1/ Logiq V2GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC20160—
+11K152758Venue 50GE Medical Systems Ultrasound and Primary Care Diagnostics201555—
+11K152577Ultrasound System Sonimage HS 1Konica Minolta, Inc.201532
+11K143601U-LiteSonoscanner Sarl20153—
+11K143027Xario 200, V3.0Toshibamedical Systems Corporation201451
+11K142517SoftVueDelphinus Medical Technologies, Inc.201449—
+11K141768Logiq V5/Logiq V3GE Healthcare201457—
+11K141675Voluson P6, Voluson P8GE Healthcare201414—
+11K141067Vivid T8/Vivid T8 ProGE Healthcare201419—
+11K133277XARIO 100Toshibamedical Systems Corporation20142—
+11K132913Voluson E6 / E8 / E8EXPERT / E8EXPERT Limited Edition / E10GE Healthcare2013255—
+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—
+12K260398LOGIQ eGE Medical Systems Ultrasound and Primary Care Diagnostics20260—
+12K253049Resona A10S, Resona A20 Pro, Resona A20T, Resona A20S, Resona A20W, Resona A20, Resona…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20260—
+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—
+12K251827Azurion R3.1Philips Medical Systems B.V.20251—
+12K251651EPIQ Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC20251—
+12K251169Vivid PioneerGE Medical Systems Ultrasound and Primary Care Diagnostics20250—
+12K243376uAngio AVIVA CXShanghai United Imaging Healthcare Co., Ltd.20251—
+12K241222Ventripoint Medical System Plus (VMS+) 4.0Ventripoint Diagnostics, Ltd.20250—
+12K242168Voluson Expert 18; Voluson Expert 20; Voluson Expert 22GE Medical Systems Ultrasound and Primary Care Diagnostics20241—
+12K242444HERA W10 Diagnostic Ultrasound System; HERA W9 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20240—
+12K242005Versana Premier; Versana Premier Lotus; LOGIQ FGE Medical Systems Ultrasound and Primary Care Diagnostics202402
+12K233977VelacurSonic Incytes20241—
+12K240906TE Air Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.20241—
+12K240111VenueGE Medical Systems Ultrasound and Primary Care Diagnostics20242—
+12K232381LOGIQ TotusGE Medical Systems Ultrasound and Primary Care Diagnostics20231—
+12K231941ARIETTA x10FUJIFILM Healthcare Americas Corporation20230—
+12K231966Logiq E10GE Medical Systems Ultrasound and Primary Care Diagnostics20235—
+12K231989LOGIQ E10s, LOGIQ FortisGe Medical Systems Ultrasound and Primary Care Diagnostic,20235—
+12K231772V8/H8 Diagnostic Ultrasound System, V7/H7 Diagnostic Ultrasound System, V6/H6 Diagnostic…Samsung Medison Co., Ltd.20238—
+12K220848Venue FitGE Medical Systems202241
+12K220800Venue GoGE Medical Systems Ultrasound and Primary Care Diagnostics202232
+12K220919MULTIX Impact ESiemens Medical Solutions USA, Inc.20222—
+12K213700MULTIX Impact, MULTIX Impact CSiemens Medical Solutions USA, Inc.20212—
+12K202422Arietta 65Hitachi Healthcare Americas20200—
+12K191233Arietta 750Hitachi Healthcare Americas201901
+12K190248Arietta 50Hitachi Healthcare Americas20191—
+12K180374Voluson S8/ Voluson S10/ Voluson S10 ExpertGE Healthcare201821
+12K172256SoftVueDelphinus Medical Technologies20180—
+12K171164U-Lite EXPSonoscanner20172—
+12K162372QT Ultrasound Breast Scanner-1Qt Ultrasound, LLC20174—
+12K163596LOGIQ P9 and LOGIQ P7GE Healthcare201747—
+12K162155Xario 200 Diagnostic Ultrasound System V5.0Toshibamedical Systems Corporation201641
+12K161224LOGIQ V5 Expert, LOGIQ V5, LOGIQ V3GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC201611—
+12K160162Voluson P6, Voluson P8GE Healthcare201613—
+12K142472Voluson E6 / Voluson E8 / Voluson E10 Diagnostic Ultrasound SystemsGE Healthcare2015187—
+12K143046Xario 100, V3.0Toshibamedical Systems Corporation201411
+13K260488MULTIX Impact; MULTIX Impact CSiemens Medical Solutions USA, Inc.20260—
+13K253726uAngio AVIVA CXShanghai United Imaging Healthcare Co., Ltd.20260—
+13K261211Philips EPIQ Series Diagnostic Ultrasound System; Philips Affiniti Series Diagnostic…Philips Ultrasound, LLC20260—
+13K253720uSONIQUE Nova, uSONIQUE Nova Elite, uSONIQUE Vita, uSONIQUE Vita Elite, uSONIQUE Grace…Wuhan United Imaging Healthcare Co.,Ltd20260—
+13K253716uSONIQUE Genesis, uSONIQUE Genesis Pro, uSONIQUE Genesis Elite, uSONIQUE Genesis Super…Wuhan United Imaging Healthcare Co.,Ltd20260—
+13K254186Azurion R3.1Philips Medical Systems B.V.20260—
+13K253370LOGIQ TotusGE Medical Systems Ultrasound and Primary Care Diagnostics20260—
+13K253366LOGIQ FortisGE Medical Systems Ultrasound and Primary Care Diagnostics20262—
+13K252328Voluson Expert 18; Voluson Expert 20; Voluson Expert 22GE Medical Systems Ultrasound and Primary Care Diagnostics20250—
+13K251985Logiq E10GE Medical Systems Ultrasound and Primary Care Diagnostics20250—
+13K251963LOGIQ E10sGE Medical Systems Ultrasound and Primary Care Diagnostics20250—
+13K251322Venue; Venue Go; Venue Fit; Venue SprintGE Medical Systems Ultrasound and Primary Care Diagnostics20251—
+13K251728Velacur One (LI-1100)Sonic Incytes Medical Corp20250—
+13K250024TE Air Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.20250—
+13K242499Digital Radiography X-ray System (SONTU100-RAD (E) , SONTU300-Mars (E))Shenzhen Sontu Medical Imaging Equipment Co., Ltd.20250—
+13K240676ULTIMUS Series Ultrasound Diagnostic SystemVinno Technology (Suzhou) Co.,Ltd20240—
+13K241029SpineUs™ SystemVerdure Imaging20240—
+13K240631V8/XV8/XH8, V7/XV7/XH7, V6/XV6/XH6 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20247—
+13K240053Venue GoGE Medical Systems Ultrasound and Primary Care Diagnostics202421
+13K240206Venue SprintGE Medical Systems Ultrasound and Primary Care Diagnostics20242—
+13K234106Venue FitGE Medical Systems Ultrasound and Primary Care Diagnostics202421
+13K233532MULTIX Impact ESiemens Medical Solutions20230—
+13K220295Arietta 50Fujifilm Healthcare Corporation20220—