510(k) Report

Devices descending from K042593

930 later devices reach Acuson Acunav 8F Ultrasound Catheter through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+13K231509Aco Apache Ultrasound SystemAco Healthcare Co., Ltd.20230—
+13K232704Clarius Ultrasound ScannerClarius Mobile Health Corp.20230—
+13K232459VelacurSonic Incytes20232—
+13K231190EPIQ Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC202314
+13K230084HERA W10 Diagnostic Ultrasound System; HERA W9 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20231—
+13K223564X-Cube 50, X-Cube 60Alpinion Medical Systems Co., Ltd.20230—
+13K223407Versana EssentialGE Medical Systems Ultrasound and Primary Care Diagnostics20230—
+13K223387V8 Diagnostic Ultrasound System, V7 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.202311—
+13K222198Exo Iris (El2001)Exo Imaging, Inc.20220—
+13K221599HS40 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20220—
+13K220619Vivid S60N, Vivid S70NGE Medical Systems Ultrasound and Primary Care Diagnostics202222
+13K220851VenueGE Medical Systems20223—
+13K220848Venue FitGE Medical Systems202241
+13K220800Venue GoGE Medical Systems Ultrasound and Primary Care Diagnostics202232
+13K220358Voluson Expert 22, Voluson Expert 20, Voluson Expert 18GE Medical Systems Ultrasound and Primary Care Diagnostics20223—
+13K220269HM70 EVO Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20223—
+13K220295Arietta 50Fujifilm Healthcare Corporation20220—
+13K213642Voluson S6, Voluson S8, Voluson S8t, Voluson S10, Voluson S10 ExpertGE Healthcare20221—
+13K210432LELTEK Ultrasound Imaging System (Model: LU700 Series)Leltek, Inc.20218—
+13K210438Versana PremierGE Medical Systems Ultrasound and Primary Care Diagnostics20211—
+13K211488Logiq E10GE Healthcare202111—
+13K211524LOGIQ E10s, LOGIQ FortisGE Healthcare20218—
+13K202658Vivid E80/ Vivid E90/ Vivid E95GE Medical Systems Ultrasound and Primary Care Diagnostics20215—
+13K201988T-LiteSonoscanner20201—
+13K202364Aplio a550, Aplio a450, Aplio a, Diagnostic Ultrasound System, Software V5.1Canon Medical Systems Corporation20201—
+13K202160Sonosite PX Ultrasound System, Sonosite SII Ultrasound System, Sonosite iViz Ultrasound…FUJIFILM Sonosite, Inc.20200—
+13K181783Logiq P9; Logiq P7GE Healthcare2018171
+13K180535Voluson P6 and Voluson P8GE Healthcare2018121
+13K172256SoftVueDelphinus Medical Technologies20180—
+13K162372QT Ultrasound Breast Scanner-1Qt Ultrasound, LLC20174—
+13K162155Xario 200 Diagnostic Ultrasound System V5.0Toshibamedical Systems Corporation201641
+13K152567Voluson E6, Voluson E8, Voluson E10 Diagnostic Ultrasound SystemGE Healthcare2015154—
+13K143046Xario 100, V3.0Toshibamedical Systems Corporation201411
+14K262390BoneXpertVisiana20260—
+14K253452Accuro 3SRivanna Medical, Inc.20260—
+14K260844ACUSON Sequoia Diagnostic Ultrasound System;ACUSON Sequoia Select Diagnostic Ultrasound…Siemens Medical Solutions USA, Inc.20260—
+14K254021Accuro XVRivanna Medical, Inc.20260—
+14K252148Butterfly Gestational Age ToolButterfly Network, Inc.20260—
+14K250914MediAI-BACrescom Co., Ltd.20250—
+14K251455EPIQ Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC20250—
+14K250886EPIQ Series Diagnostic Ultrasound Systems; Affiniti Series Diagnostic Ultrasound SystemsPhilips Ultrasound, LLC20250—
+14K243793EPIQ Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC20250—
+14K242808Aplio i900/i800/i700 Diagnostic Ultrasound System, Software V8.5Canon Medical Systems Corporation20252—
+14K251110EPIQ Series Diagnostic Ultrasound Systems; Affiniti Series Diagnostic Ultrasound SystemsPhilips Ultrasound, LLC20250—
+14K243794EPIQ Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC20255—
+14K242168Voluson Expert 18; Voluson Expert 20; Voluson Expert 22GE Medical Systems Ultrasound and Primary Care Diagnostics20241—
+14K242020EPIQ Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC20243—
+14K242444HERA W10 Diagnostic Ultrasound System; HERA W9 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20240—
+14K242005Versana Premier; Versana Premier Lotus; LOGIQ FGE Medical Systems Ultrasound and Primary Care Diagnostics202402
+14K233977VelacurSonic Incytes20241—
+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
+14K240111VenueGE Medical Systems Ultrasound and Primary Care Diagnostics20242—
+14K233692Voluson Signature 20, Voluson Signature 18GE Medical Systems Ultrasound and Primary Care Diagnostics20240—
+14K232285U-Lite PROSonoscanner Sarl20240—
+14K233112HM70 EVO Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20232—
+14K232381LOGIQ TotusGE Medical Systems Ultrasound and Primary Care Diagnostics20231—
+14K233545EPIQ Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC202301
+14K231966Logiq E10GE Medical Systems Ultrasound and Primary Care Diagnostics20235—
+14K231989LOGIQ E10s, LOGIQ FortisGe Medical Systems Ultrasound and Primary Care Diagnostic,20235—
+14K231965Voluson Expert 22, Voluson Expert 20, Voluson Expert 18GE Medical Systems Ultrasound and Primary Care Diagnostics20232—
+14K231772V8/H8 Diagnostic Ultrasound System, V7/H7 Diagnostic Ultrasound System, V6/H6 Diagnostic…Samsung Medison Co., Ltd.20238—
+14K223832Vivid S60N, Vivid S70NGe Medical System Ultrasound and Primary Care Diagnostics202312
+14K222365Leltek Ultrasound Imaging System (Model: LU700 Series)Leltek, Inc.20227—
+14K220882Vivid E80, Vivid E90, Vivid E95Ge Medical Systems Ultrasound And20222—
+14K212960Aplio a550, Aplio a450, and Aplio a, Diagnostic Ultrasound System, Software V6.5Canon Medical Systems Corporation202201
+14K213689Voluson P6, Voluson P8GE Healthcare20220—
+14K203114Logiq P10, Logiq P9, Logiq P8GE Medical Systems Ultrasound and Primary Care Diagnostics20211—
+14K201828Voluson SWIFT, Voluson SWIFT+GE Medical Systems Ultrasound and Primary Care Diagnostics202010—
+14K182213QT Ultrasound Breast Scanner - 1Qt Ultrasound, LLC20183—
+14K172276Xario 200 Diagnostic Ultrasound System V6.0Toshibamedical Systems Corporation20173—
+14K162187Xario 100 Diagnostic Ultrasound System, V5.0Toshibamedical Systems Corporation201601
+15K261313Vivid Explorer/Vivid Advanced/Vivid FocusGE Medical Systems Ultrasound and Primary Care Diagnostics20260—
+15K260667Alturion Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC20261—
+15K260680EPIQ Series Diagnostic Ultrasound Systems; Affiniti Series Diagnostic Ultrasound SystemsPhilips Ultrasound, LLC202601
+15K253720uSONIQUE Nova, uSONIQUE Nova Elite, uSONIQUE Vita, uSONIQUE Vita Elite, uSONIQUE Grace…Wuhan United Imaging Healthcare Co.,Ltd20260—
+15K253716uSONIQUE Genesis, uSONIQUE Genesis Pro, uSONIQUE Genesis Elite, uSONIQUE Genesis Super…Wuhan United Imaging Healthcare Co.,Ltd20260—
+15K254099EVO Q30 Diagnostic Ultrasound System; EVO Q20 Diagnostic Ultrasound System; EVO Q10…Samsung Medison Co., Ltd.20261—
+15K253595EPIQ Series Diagnostic Ultrasound System, Affiniti Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC20261—
+15K253597Aplio beyond and Aplio me Software V2.0 Diagnostic Ultrasound SystemCanon Medical Systems Corporation20260—
+15K253370LOGIQ TotusGE Medical Systems Ultrasound and Primary Care Diagnostics20260—
+15K253366LOGIQ FortisGE Medical Systems Ultrasound and Primary Care Diagnostics20262—
+15K250791ASUS Ultrasound Imaging System (LU800 series)Asustek Computer, Inc.20250—
+15K252328Voluson Expert 18; Voluson Expert 20; Voluson Expert 22GE Medical Systems Ultrasound and Primary Care Diagnostics20250—
+15K252074Aplio i900, Aplio i800 and Aplio i700 Software V9.0 Diagnostic Ultrasound SystemCanon Medical Systems Corporation20250—
+15K251985Logiq E10GE Medical Systems Ultrasound and Primary Care Diagnostics20250—
+15K251963LOGIQ E10sGE Medical Systems Ultrasound and Primary Care Diagnostics20250—
+15K251322Venue; Venue Go; Venue Fit; Venue SprintGE Medical Systems Ultrasound and Primary Care Diagnostics20251—
+15K251169Vivid PioneerGE Medical Systems Ultrasound and Primary Care Diagnostics20250—
+15K251728Velacur One (LI-1100)Sonic Incytes Medical Corp20250—
+15K250177EPIQ Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC20252—
+15K242681NUSONO Handheld Ultrasound Scanner (NUSONO-C35); NUSONO Handheld Ultrasound Scanner…Nurodata, Inc.20251—
+15K240676ULTIMUS Series Ultrasound Diagnostic SystemVinno Technology (Suzhou) Co.,Ltd20240—
+15K241029SpineUs™ SystemVerdure Imaging20240—
+15K241161Ultrasound Imaging System (LK128L); Ultrasound Imaging System (LK128LH); Ultrasound…Leltek, Inc.20243—
+15K240631V8/XV8/XH8, V7/XV7/XH7, V6/XV6/XH6 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20247—
+15K230365Sonio DetectSonio20237—
+15K230346Voluson SWIFT; Voluson SWIFT+Ge Medical Systems Ultrasound & Primary Care Diagnostic, LLC20231—
+15K214039Logiq P10, Logiq P9, Logiq P8GE Medical Systems Ultrasound and Primary Care Diagnostics202203