510(k) Report

Devices descending from K033650

945 later devices reach Acunav 90/10 Diagnostic Ultrasound Catheter through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+14K251268Diagnostic Ultrasound System (Nano C5, Nano C5 EXP, Nano L12, and Nano L12 EXP)Edan Instruments, Inc.20250—
+14K251481ACUSON Sequoia Diagnostic Ultrasound System; ACUSON Sequoia Select Diagnostic Ultrasound…Siemens Medical Solutions USA, Inc.20251—
+14K251456BrightHeart View ClassifierBrightheart20250—
+14K243937Accuro 3SRivanna Medical, Inc.20252—
+14K243620Vivid iqGE Medical Systems Ultrasound and Primary Care Diagnostics20250—
+14K242496Portable Liver Elastography Ultrasound Diagnostic System (Liverscan C)Eieling Technology (Shenzhen) Limited20240—
+14K240980EPIQ Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC20240—
+14K241582Aplio i900/i800/i700 Diagnostic Ultrasound System, Software V7.0 (TUS-AI900, TUS-AI800…Canon Medical Systems Corporation20240—
+14K233579SC1 Handheld Ultrasound Imaging system (Model: SC1)Fcu Co., Ltd.20240—
+14K240516RS85 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20240—
+14K234042EFAI Bonesuite XR Bone Age Pro Assessment System (BAP-XR-100)Ever Fortune.Ai, Co., Ltd.20242—
+14K240850EPIQ Series Diagnostic Ultrasound Systems; Affiniti Series Diagnostic Ultrasound SystemsPhilips Ultrasound, LLC202414—
+14K231930Digital Ultrasonic Diagnostic Imaging System (Model: F6)Guangdong Youkey Medical Co., Ltd.20240—
+14K233195Aplio i900, Aplio i800 and Aplio i700 Software V8.1 Diagnostic Ultrasound SystemCanon Medical Systems Corporation20243—
+14K232808Butterfly iQ3 Ultrasound SystemButterfly Network, Inc.20241—
+14K231509Aco Apache Ultrasound SystemAco Healthcare Co., Ltd.20230—
+14K232704Clarius Ultrasound ScannerClarius Mobile Health Corp.20230—
+14K232459VelacurSonic Incytes20232—
+14K231190EPIQ Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC202314
+14K230084HERA W10 Diagnostic Ultrasound System; HERA W9 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20231—
+14K223564X-Cube 50, X-Cube 60Alpinion Medical Systems Co., Ltd.20230—
+14K223407Versana EssentialGE Medical Systems Ultrasound and Primary Care Diagnostics20230—
+14K223387V8 Diagnostic Ultrasound System, V7 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.202311—
+14K222198Exo Iris (El2001)Exo Imaging, Inc.20220—
+14K221599HS40 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20220—
+14K220619Vivid S60N, Vivid S70NGE Medical Systems Ultrasound and Primary Care Diagnostics202222
+14K220851VenueGE Medical Systems20223—
+14K220848Venue FitGE Medical Systems202241
+14K220800Venue GoGE Medical Systems Ultrasound and Primary Care Diagnostics202232
+14K220358Voluson Expert 22, Voluson Expert 20, Voluson Expert 18GE Medical Systems Ultrasound and Primary Care Diagnostics20223—
+14K220269HM70 EVO Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20223—
+14K220295Arietta 50Fujifilm Healthcare Corporation20220—
+14K213642Voluson S6, Voluson S8, Voluson S8t, Voluson S10, Voluson S10 ExpertGE Healthcare20221—
+14K210432LELTEK Ultrasound Imaging System (Model: LU700 Series)Leltek, Inc.20218—
+14K210438Versana PremierGE Medical Systems Ultrasound and Primary Care Diagnostics20211—
+14K211488Logiq E10GE Healthcare202111—
+14K211524LOGIQ E10s, LOGIQ FortisGE Healthcare20218—
+14K202658Vivid E80/ Vivid E90/ Vivid E95GE Medical Systems Ultrasound and Primary Care Diagnostics20215—
+14K201988T-LiteSonoscanner20201—
+14K202364Aplio a550, Aplio a450, Aplio a, Diagnostic Ultrasound System, Software V5.1Canon Medical Systems Corporation20201—
+14K202160Sonosite PX Ultrasound System, Sonosite SII Ultrasound System, Sonosite iViz Ultrasound…FUJIFILM Sonosite, Inc.20200—
+14K181783Logiq P9; Logiq P7GE Healthcare2018171
+14K180535Voluson P6 and Voluson P8GE Healthcare2018121
+14K172256SoftVueDelphinus Medical Technologies20180—
+14K162372QT Ultrasound Breast Scanner-1Qt Ultrasound, LLC20174—
+14K162155Xario 200 Diagnostic Ultrasound System V5.0Toshibamedical Systems Corporation201641
+14K152567Voluson E6, Voluson E8, Voluson E10 Diagnostic Ultrasound SystemGE Healthcare2015154—
+14K143046Xario 100, V3.0Toshibamedical Systems Corporation201411
+15K262390BoneXpertVisiana20260—
+15K253452Accuro 3SRivanna Medical, Inc.20260—
+15K260844ACUSON Sequoia Diagnostic Ultrasound System;ACUSON Sequoia Select Diagnostic Ultrasound…Siemens Medical Solutions USA, Inc.20260—
+15K254021Accuro XVRivanna Medical, Inc.20260—
+15K252148Butterfly Gestational Age ToolButterfly Network, Inc.20260—
+15K250914MediAI-BACrescom Co., Ltd.20250—
+15K251455EPIQ Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC20250—
+15K250886EPIQ Series Diagnostic Ultrasound Systems; Affiniti Series Diagnostic Ultrasound SystemsPhilips Ultrasound, LLC20250—
+15K243793EPIQ Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC20250—
+15K242808Aplio i900/i800/i700 Diagnostic Ultrasound System, Software V8.5Canon Medical Systems Corporation20252—
+15K251110EPIQ Series Diagnostic Ultrasound Systems; Affiniti Series Diagnostic Ultrasound SystemsPhilips Ultrasound, LLC20250—
+15K243794EPIQ Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC20255—
+15K242168Voluson Expert 18; Voluson Expert 20; Voluson Expert 22GE Medical Systems Ultrasound and Primary Care Diagnostics20241—
+15K242020EPIQ Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC20243—
+15K242444HERA W10 Diagnostic Ultrasound System; HERA W9 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20240—
+15K242005Versana Premier; Versana Premier Lotus; LOGIQ FGE Medical Systems Ultrasound and Primary Care Diagnostics202402
+15K233977VelacurSonic Incytes20241—
+15K240053Venue GoGE Medical Systems Ultrasound and Primary Care Diagnostics202421
+15K240206Venue SprintGE Medical Systems Ultrasound and Primary Care Diagnostics20242—
+15K234106Venue FitGE Medical Systems Ultrasound and Primary Care Diagnostics202421
+15K240111VenueGE Medical Systems Ultrasound and Primary Care Diagnostics20242—
+15K233692Voluson Signature 20, Voluson Signature 18GE Medical Systems Ultrasound and Primary Care Diagnostics20240—
+15K232285U-Lite PROSonoscanner Sarl20240—
+15K233112HM70 EVO Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20232—
+15K232381LOGIQ TotusGE Medical Systems Ultrasound and Primary Care Diagnostics20231—
+15K233545EPIQ Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC202301
+15K231966Logiq E10GE Medical Systems Ultrasound and Primary Care Diagnostics20235—
+15K231989LOGIQ E10s, LOGIQ FortisGe Medical Systems Ultrasound and Primary Care Diagnostic,20235—
+15K231965Voluson Expert 22, Voluson Expert 20, Voluson Expert 18GE Medical Systems Ultrasound and Primary Care Diagnostics20232—
+15K231772V8/H8 Diagnostic Ultrasound System, V7/H7 Diagnostic Ultrasound System, V6/H6 Diagnostic…Samsung Medison Co., Ltd.20238—
+15K223832Vivid S60N, Vivid S70NGe Medical System Ultrasound and Primary Care Diagnostics202312
+15K222365Leltek Ultrasound Imaging System (Model: LU700 Series)Leltek, Inc.20227—
+15K220882Vivid E80, Vivid E90, Vivid E95Ge Medical Systems Ultrasound And20222—
+15K212960Aplio a550, Aplio a450, and Aplio a, Diagnostic Ultrasound System, Software V6.5Canon Medical Systems Corporation202201
+15K213689Voluson P6, Voluson P8GE Healthcare20220—
+15K203114Logiq P10, Logiq P9, Logiq P8GE Medical Systems Ultrasound and Primary Care Diagnostics20211—
+15K201828Voluson SWIFT, Voluson SWIFT+GE Medical Systems Ultrasound and Primary Care Diagnostics202010—
+15K182213QT Ultrasound Breast Scanner - 1Qt Ultrasound, LLC20183—
+15K172276Xario 200 Diagnostic Ultrasound System V6.0Toshibamedical Systems Corporation20173—
+15K162187Xario 100 Diagnostic Ultrasound System, V5.0Toshibamedical Systems Corporation201601
+16K261313Vivid Explorer/Vivid Advanced/Vivid FocusGE Medical Systems Ultrasound and Primary Care Diagnostics20260—
+16K260667Alturion Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC20261—
+16K260680EPIQ Series Diagnostic Ultrasound Systems; Affiniti Series Diagnostic Ultrasound SystemsPhilips Ultrasound, LLC202601
+16K253720uSONIQUE Nova, uSONIQUE Nova Elite, uSONIQUE Vita, uSONIQUE Vita Elite, uSONIQUE Grace…Wuhan United Imaging Healthcare Co.,Ltd20260—
+16K253716uSONIQUE Genesis, uSONIQUE Genesis Pro, uSONIQUE Genesis Elite, uSONIQUE Genesis Super…Wuhan United Imaging Healthcare Co.,Ltd20260—
+16K254099EVO Q30 Diagnostic Ultrasound System; EVO Q20 Diagnostic Ultrasound System; EVO Q10…Samsung Medison Co., Ltd.20261—
+16K253595EPIQ Series Diagnostic Ultrasound System, Affiniti Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC20261—
+16K253597Aplio beyond and Aplio me Software V2.0 Diagnostic Ultrasound SystemCanon Medical Systems Corporation20260—
+16K253370LOGIQ TotusGE Medical Systems Ultrasound and Primary Care Diagnostics20260—
+16K253366LOGIQ FortisGE Medical Systems Ultrasound and Primary Care Diagnostics20262—
+16K250791ASUS Ultrasound Imaging System (LU800 series)Asustek Computer, Inc.20250—
+16K252328Voluson Expert 18; Voluson Expert 20; Voluson Expert 22GE Medical Systems Ultrasound and Primary Care Diagnostics20250—