510(k) Report

Devices descending from K063085

838 later devices reach Modification to Acuson Sequoia Ultrasound System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+9K201059S60 Elite Series/S70 Series Digital Color Doppler Ultrasound SystemSonoscape Medical Corp.20204—
+9K200743Vivid E80/ Vivid E90/ Vivid E95Ge Medical Systems Ultrasound And20207—
+9K193518KosmosEchoNous, Inc.20201—
+9K192107Clarius Ultrasound ScannerClarius Mobile Health Corp.201910—
+9K181783Logiq P9; Logiq P7GE Healthcare2018171
+9K180535Voluson P6 and Voluson P8GE Healthcare2018121
+9K172256SoftVueDelphinus Medical Technologies20180—
+9K172993P20 Series Digital Color Doppler Ultrasound SystemSonoscape Medical Corp.20171—
+9K173058P10 Series Digital Color Doppler Ultrasound SystemSonoscape Medical Corp.20171—
+9K162372QT Ultrasound Breast Scanner-1Qt Ultrasound, LLC20174—
+9K162155Xario 200 Diagnostic Ultrasound System V5.0Toshibamedical Systems Corporation201641
+9K152567Voluson E6, Voluson E8, Voluson E10 Diagnostic Ultrasound SystemGE Healthcare2015154—
+9K143046Xario 100, V3.0Toshibamedical Systems Corporation201411
+10K253452Accuro 3SRivanna Medical, Inc.20260—
+10K260846Diagnostic Ultrasound System (MU9);Diagnostic Ultrasound System (MU9S);Diagnostic…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20260—
+10K254021Accuro XVRivanna Medical, Inc.20260—
+10K252148Butterfly Gestational Age ToolButterfly Network, Inc.20260—
+10K251481ACUSON Sequoia Diagnostic Ultrasound System; ACUSON Sequoia Select Diagnostic Ultrasound…Siemens Medical Solutions USA, Inc.20251—
+10K251455EPIQ Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC20250—
+10K250913TINGSN FINDERS 2 Color Doppler Diagnostic Ultrasound SystemJiangsu Tingsn Technology Co., Ltd.20250—
+10K251342EchoPAC Software Only / EchoPAC Plug-inGE Medical Systems Ultrasound and Primary Care Diagnostics20251—
+10K250886EPIQ Series Diagnostic Ultrasound Systems; Affiniti Series Diagnostic Ultrasound SystemsPhilips Ultrasound, LLC20250—
+10K243793EPIQ Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC20250—
+10K242808Aplio i900/i800/i700 Diagnostic Ultrasound System, Software V8.5Canon Medical Systems Corporation20252—
+10K251110EPIQ Series Diagnostic Ultrasound Systems; Affiniti Series Diagnostic Ultrasound SystemsPhilips Ultrasound, LLC20250—
+10K243628Vivid T9/Vivid T8GE Medical Systems Ultrasound and Primary Care Diagnostics20250—
+10K243620Vivid iqGE Medical Systems Ultrasound and Primary Care Diagnostics20250—
+10K243794EPIQ Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC20255—
+10K242168Voluson Expert 18; Voluson Expert 20; Voluson Expert 22GE Medical Systems Ultrasound and Primary Care Diagnostics20241—
+10K242020EPIQ Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC20243—
+10K242444HERA W10 Diagnostic Ultrasound System; HERA W9 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20240—
+10K242005Versana Premier; Versana Premier Lotus; LOGIQ FGE Medical Systems Ultrasound and Primary Care Diagnostics202402
+10K234153EdgeLife Handheld Wireless Ultrasound System (E8200); EdgeLife Handheld Wireless…Edgelife Technologies, LLC20240—
+10K233977VelacurSonic Incytes20241—
+10K240906TE Air Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.20241—
+10K240053Venue GoGE Medical Systems Ultrasound and Primary Care Diagnostics202421
+10K240206Venue SprintGE Medical Systems Ultrasound and Primary Care Diagnostics20242—
+10K234106Venue FitGE Medical Systems Ultrasound and Primary Care Diagnostics202421
+10K240111VenueGE Medical Systems Ultrasound and Primary Care Diagnostics20242—
+10K233692Voluson Signature 20, Voluson Signature 18GE Medical Systems Ultrasound and Primary Care Diagnostics20240—
+10K232285U-Lite PROSonoscanner Sarl20240—
+10K233112HM70 EVO Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20232—
+10K232381LOGIQ TotusGE Medical Systems Ultrasound and Primary Care Diagnostics20231—
+10K233545EPIQ Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC202301
+10K231966Logiq E10GE Medical Systems Ultrasound and Primary Care Diagnostics20235—
+10K231989LOGIQ E10s, LOGIQ FortisGe Medical Systems Ultrasound and Primary Care Diagnostic,20235—
+10K231965Voluson Expert 22, Voluson Expert 20, Voluson Expert 18GE Medical Systems Ultrasound and Primary Care Diagnostics20232—
+10K231772V8/H8 Diagnostic Ultrasound System, V7/H7 Diagnostic Ultrasound System, V6/H6 Diagnostic…Samsung Medison Co., Ltd.20238—
+10K231301Vscan AirGE Medical Systems Ultrasound and Primary Care Diagnostics20231—
+10K222596S90 Exp Series Digital Color Doppler Ultrasound SystemSonoscape Medical Corp.20233—
+10K222365Leltek Ultrasound Imaging System (Model: LU700 Series)Leltek, Inc.20227—
+10K220619Vivid S60N, Vivid S70NGE Medical Systems Ultrasound and Primary Care Diagnostics202222
+10K211665SONON Ultrasound Imaging System, Model: SONON300CHealcerion Co., Ltd.20220—
+10K220490ImaCor Zura Handheld ZHH-010Imacor, Inc.202202
+10K212960Aplio a550, Aplio a450, and Aplio a, Diagnostic Ultrasound System, Software V6.5Canon Medical Systems Corporation202201
+10K211746Pocket Ultrasound SystemGuangdong Youkey Medical Co., Ltd.20221—
+10K213689Voluson P6, Voluson P8GE Healthcare20220—
+10K213436Clarius Ultrasound ScannerClarius Mobile Health Corp.20212—
+10K212100KosmosEchoNous, Inc.202101
+10K211232Apache Ultrasound SystemAco Healthcare Co., Ltd.20210—
+10K202658Vivid E80/ Vivid E90/ Vivid E95GE Medical Systems Ultrasound and Primary Care Diagnostics20215—
+10K203114Logiq P10, Logiq P9, Logiq P8GE Medical Systems Ultrasound and Primary Care Diagnostics20211—
+10K202074Apache Ultrasound System (Model C62)Compal Electronics, Inc.20200—
+10K201828Voluson SWIFT, Voluson SWIFT+GE Medical Systems Ultrasound and Primary Care Diagnostics202010—
+10K182648X5 Series Digital Color Doppler Ultrasound SystemSonoscape Medical Corp.20190—
+10K182213QT Ultrasound Breast Scanner - 1Qt Ultrasound, LLC20183—
+10K172276Xario 200 Diagnostic Ultrasound System V6.0Toshibamedical Systems Corporation20173—
+10K162187Xario 100 Diagnostic Ultrasound System, V5.0Toshibamedical Systems Corporation201601
+11K261623EchoPAC Software Only / EchoPAC Plug-in (v211)GE Medical Systems Ultrasound and Primary Care Diagnostics20260—
+11K254027Digital Color Doppler Ultrasound System (Marvo 95/Marvo 95 Elite/Marvo 90/Marvo 90…Sonoscape Medical Corp.20260—
+11K260667Alturion Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC20261—
+11K260844ACUSON Sequoia Diagnostic Ultrasound System;ACUSON Sequoia Select Diagnostic Ultrasound…Siemens Medical Solutions USA, Inc.20260—
+11K260680EPIQ Series Diagnostic Ultrasound Systems; Affiniti Series Diagnostic Ultrasound SystemsPhilips Ultrasound, LLC202601
+11K253720uSONIQUE Nova, uSONIQUE Nova Elite, uSONIQUE Vita, uSONIQUE Vita Elite, uSONIQUE Grace…Wuhan United Imaging Healthcare Co.,Ltd20260—
+11K254028Digital Color Doppler Ultrasound System (Autra RS, Autra 90, Autra Senior, Autra CV…Sonoscape Medical Corp.20260—
+11K253716uSONIQUE Genesis, uSONIQUE Genesis Pro, uSONIQUE Genesis Elite, uSONIQUE Genesis Super…Wuhan United Imaging Healthcare Co.,Ltd20260—
+11K254099EVO Q30 Diagnostic Ultrasound System; EVO Q20 Diagnostic Ultrasound System; EVO Q10…Samsung Medison Co., Ltd.20261—
+11K253595EPIQ Series Diagnostic Ultrasound System, Affiniti Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC20261—
+11K253597Aplio beyond and Aplio me Software V2.0 Diagnostic Ultrasound SystemCanon Medical Systems Corporation20260—
+11K253370LOGIQ TotusGE Medical Systems Ultrasound and Primary Care Diagnostics20260—
+11K253366LOGIQ FortisGE Medical Systems Ultrasound and Primary Care Diagnostics20262—
+11K252498Digital Color Doppler Ultrasound System (X11 Exp/X11 Elite/X11 Pro/X11 Plus/X11…Sonoscape Medical Corp.20250—
+11K250791ASUS Ultrasound Imaging System (LU800 series)Asustek Computer, Inc.20250—
+11K252328Voluson Expert 18; Voluson Expert 20; Voluson Expert 22GE Medical Systems Ultrasound and Primary Care Diagnostics20250—
+11K252074Aplio i900, Aplio i800 and Aplio i700 Software V9.0 Diagnostic Ultrasound SystemCanon Medical Systems Corporation20250—
+11K251985Logiq E10GE Medical Systems Ultrasound and Primary Care Diagnostics20250—
+11K251963LOGIQ E10sGE Medical Systems Ultrasound and Primary Care Diagnostics20250—
+11K251322Venue; Venue Go; Venue Fit; Venue SprintGE Medical Systems Ultrasound and Primary Care Diagnostics20251—
+11K251728Velacur One (LI-1100)Sonic Incytes Medical Corp20250—
+11K250024TE Air Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.20250—
+11K250087Vscan AirGE Medical Systems Ultrasound and Primary Care Diagnostics20250—
+11K250177EPIQ Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC20252—
+11K242681NUSONO Handheld Ultrasound Scanner (NUSONO-C35); NUSONO Handheld Ultrasound Scanner…Nurodata, Inc.20251—
+11K240676ULTIMUS Series Ultrasound Diagnostic SystemVinno Technology (Suzhou) Co.,Ltd20240—
+11K241029SpineUs™ SystemVerdure Imaging20240—
+11K241161Ultrasound Imaging System (LK128L); Ultrasound Imaging System (LK128LH); Ultrasound…Leltek, Inc.20243—
+11K240631V8/XV8/XH8, V7/XV7/XH7, V6/XV6/XH6 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20247—
+11K231930Digital Ultrasonic Diagnostic Imaging System (Model: F6)Guangdong Youkey Medical Co., Ltd.20240—
+11K231509Aco Apache Ultrasound SystemAco Healthcare Co., Ltd.20230—
+11K232704Clarius Ultrasound ScannerClarius Mobile Health Corp.20230—