510(k) Report

Devices descending from K933202

1,018 later devices reach Venus Diagnostic Ultrasound System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+15K260589ES-SeriesE-Scopics20260—
+15K253595EPIQ Series Diagnostic Ultrasound System, Affiniti Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC20261—
+15K253049Resona A10S, Resona A20 Pro, Resona A20T, Resona A20S, Resona A20W, Resona A20, Resona…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20260—
+15K253221Liver fat ultrasound quantitative system, The FattaLab (FL-CC M1, FL-CC M1_Pro)Eieling Technology (Shenzhen) Limited20260—
+15K250914MediAI-BACrescom Co., Ltd.20250—
+15K251853Consona N5, Consona N5 Pro, Consona N5 Super, Consona N5 Exp, Consona ER, Consona N5S…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20251—
+15K251192Diagnostic Ultrasound System (MX7); Diagnostic Ultrasound System (MX7T); Diagnostic…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20250—
+15K250110Diagnostic Ultrasound System (MX6); Diagnostic Ultrasound System (MX6S); Diagnostic…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20250—
+15K250177EPIQ Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC20252—
+15K242496Portable Liver Elastography Ultrasound Diagnostic System (Liverscan C)Eieling Technology (Shenzhen) Limited20240—
+15K242523ACUSON Sequoia Diagnostic Ultrasound System; ACUSON Sequoia Select Diagnostic Ultrasound…Siemens Medical Solutions USA, Inc.20242—
+15K241582Aplio i900/i800/i700 Diagnostic Ultrasound System, Software V7.0 (TUS-AI900, TUS-AI800…Canon Medical Systems Corporation20240—
+15K240516RS85 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20240—
+15K233195Aplio i900, Aplio i800 and Aplio i700 Software V8.1 Diagnostic Ultrasound SystemCanon Medical Systems Corporation20243—
+15K231965Voluson Expert 22, Voluson Expert 20, Voluson Expert 18GE Medical Systems Ultrasound and Primary Care Diagnostics20232—
+15K232459VelacurSonic Incytes20232—
+15K231190EPIQ Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC202314
+15K230084HERA W10 Diagnostic Ultrasound System; HERA W9 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20231—
+15K223564X-Cube 50, X-Cube 60Alpinion Medical Systems Co., Ltd.20230—
+15K223832Vivid S60N, Vivid S70NGe Medical System Ultrasound and Primary Care Diagnostics202312
+15K223387V8 Diagnostic Ultrasound System, V7 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.202311—
+15K221599HS40 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20220—
+15K220882Vivid E80, Vivid E90, Vivid E95Ge Medical Systems Ultrasound And20222—
+15K220851VenueGE Medical Systems20223—
+15K220848Venue FitGE Medical Systems202241
+15K220800Venue GoGE Medical Systems Ultrasound and Primary Care Diagnostics202232
+15K220269HM70 EVO Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20223—
+15K220295Arietta 50Fujifilm Healthcare Corporation20220—
+15K220051TE Air Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.20223—
+15K213642Voluson S6, Voluson S8, Voluson S8t, Voluson S10, Voluson S10 ExpertGE Healthcare20221—
+15K210438Versana PremierGE Medical Systems Ultrasound and Primary Care Diagnostics20211—
+15K211488Logiq E10GE Healthcare202111—
+15K211524LOGIQ E10s, LOGIQ FortisGE Healthcare20218—
+15K201988T-LiteSonoscanner20201—
+15K202364Aplio a550, Aplio a450, Aplio a, Diagnostic Ultrasound System, Software V5.1Canon Medical Systems Corporation20201—
+15K181783Logiq P9; Logiq P7GE Healthcare2018171
+15K180535Voluson P6 and Voluson P8GE Healthcare2018121
+15K172256SoftVueDelphinus Medical Technologies20180—
+15K162372QT Ultrasound Breast Scanner-1Qt Ultrasound, LLC20174—
+15K162155Xario 200 Diagnostic Ultrasound System V5.0Toshibamedical Systems Corporation201641
+15K152567Voluson E6, Voluson E8, Voluson E10 Diagnostic Ultrasound SystemGE Healthcare2015154—
+15K143046Xario 100, V3.0Toshibamedical Systems Corporation201411
+16K261313Vivid Explorer/Vivid Advanced/Vivid FocusGE Medical Systems Ultrasound and Primary Care Diagnostics20260—
+16K262311Alturion Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC20260—
+16K260846Diagnostic Ultrasound System (MU9);Diagnostic Ultrasound System (MU9S);Diagnostic…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20260—
+16K251651EPIQ Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC20251—
+16K251481ACUSON Sequoia Diagnostic Ultrasound System; ACUSON Sequoia Select Diagnostic Ultrasound…Siemens Medical Solutions USA, Inc.20251—
+16K251169Vivid PioneerGE Medical Systems Ultrasound and Primary Care Diagnostics20250—
+16K242808Aplio i900/i800/i700 Diagnostic Ultrasound System, Software V8.5Canon Medical Systems Corporation20252—
+16K242168Voluson Expert 18; Voluson Expert 20; Voluson Expert 22GE Medical Systems Ultrasound and Primary Care Diagnostics20241—
+16K242444HERA W10 Diagnostic Ultrasound System; HERA W9 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20240—
+16K242005Versana Premier; Versana Premier Lotus; LOGIQ FGE Medical Systems Ultrasound and Primary Care Diagnostics202402
+16K233977VelacurSonic Incytes20241—
+16K240053Venue GoGE Medical Systems Ultrasound and Primary Care Diagnostics202421
+16K240206Venue SprintGE Medical Systems Ultrasound and Primary Care Diagnostics20242—
+16K234106Venue FitGE Medical Systems Ultrasound and Primary Care Diagnostics202421
+16K240111VenueGE Medical Systems Ultrasound and Primary Care Diagnostics20242—
+16K233692Voluson Signature 20, Voluson Signature 18GE Medical Systems Ultrasound and Primary Care Diagnostics20240—
+16K232285U-Lite PROSonoscanner Sarl20240—
+16K233112HM70 EVO Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20232—
+16K232381LOGIQ TotusGE Medical Systems Ultrasound and Primary Care Diagnostics20231—
+16K233545EPIQ Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC202301
+16K231966Logiq E10GE Medical Systems Ultrasound and Primary Care Diagnostics20235—
+16K231989LOGIQ E10s, LOGIQ FortisGe Medical Systems Ultrasound and Primary Care Diagnostic,20235—
+16K231685TE Air Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.20232—
+16K231772V8/H8 Diagnostic Ultrasound System, V7/H7 Diagnostic Ultrasound System, V6/H6 Diagnostic…Samsung Medison Co., Ltd.20238—
+16K212960Aplio a550, Aplio a450, and Aplio a, Diagnostic Ultrasound System, Software V6.5Canon Medical Systems Corporation202201
+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—
+16K182213QT Ultrasound Breast Scanner - 1Qt Ultrasound, LLC20183—
+16K172276Xario 200 Diagnostic Ultrasound System V6.0Toshibamedical Systems Corporation20173—
+16K162187Xario 100 Diagnostic Ultrasound System, V5.0Toshibamedical Systems Corporation201601
+17K261211Philips EPIQ Series Diagnostic Ultrasound System; Philips Affiniti Series Diagnostic…Philips Ultrasound, LLC20260—
+17K260844ACUSON Sequoia Diagnostic Ultrasound System;ACUSON Sequoia Select Diagnostic Ultrasound…Siemens Medical Solutions USA, Inc.20260—
+17K253720uSONIQUE Nova, uSONIQUE Nova Elite, uSONIQUE Vita, uSONIQUE Vita Elite, uSONIQUE Grace…Wuhan United Imaging Healthcare Co.,Ltd20260—
+17K253716uSONIQUE Genesis, uSONIQUE Genesis Pro, uSONIQUE Genesis Elite, uSONIQUE Genesis Super…Wuhan United Imaging Healthcare Co.,Ltd20260—
+17K254099EVO Q30 Diagnostic Ultrasound System; EVO Q20 Diagnostic Ultrasound System; EVO Q10…Samsung Medison Co., Ltd.20261—
+17K253597Aplio beyond and Aplio me Software V2.0 Diagnostic Ultrasound SystemCanon Medical Systems Corporation20260—
+17K253370LOGIQ TotusGE Medical Systems Ultrasound and Primary Care Diagnostics20260—
+17K253366LOGIQ FortisGE Medical Systems Ultrasound and Primary Care Diagnostics20262—
+17K252328Voluson Expert 18; Voluson Expert 20; Voluson Expert 22GE Medical Systems Ultrasound and Primary Care Diagnostics20250—
+17K252074Aplio i900, Aplio i800 and Aplio i700 Software V9.0 Diagnostic Ultrasound SystemCanon Medical Systems Corporation20250—
+17K251985Logiq E10GE Medical Systems Ultrasound and Primary Care Diagnostics20250—
+17K251963LOGIQ E10sGE Medical Systems Ultrasound and Primary Care Diagnostics20250—
+17K251322Venue; Venue Go; Venue Fit; Venue SprintGE Medical Systems Ultrasound and Primary Care Diagnostics20251—
+17K251728Velacur One (LI-1100)Sonic Incytes Medical Corp20250—
+17K240676ULTIMUS Series Ultrasound Diagnostic SystemVinno Technology (Suzhou) Co.,Ltd20240—
+17K241029SpineUs™ SystemVerdure Imaging20240—
+17K240906TE Air Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.20241—
+17K240631V8/XV8/XH8, V7/XV7/XH7, V6/XV6/XH6 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20247—
+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
+17K190646QT Scanner 2000 Model AQt Ultrasound, LLC20192—
+17K182596Xario200G and Xario100G, Software V1.1 Diagnostic Ultrasound SystemCanon Medical Systems Corporation20182—
+18K263182EVO X30 Diagnostic Ultrasound System; EVO X20 Diagnostic Ultrasound System; EVO X10…Samsung Medison Co., Ltd.20260—
+18K261668Venue GoGE Medical Systems Ultrasound and Primary care Diagnostics, LLC20260—
+18K261835LOGIQ FocusGE Medical Systems Ultrasound and Primary Care Diagnostics20260—
+18K260673LOGIQ Vita; LOGIQ Vita Pro; LOGIQ Vita Express; LOGIQ Vita Plus; LOGIQ Vita Power; LOGIQ…GE Medical Systems Ultrasound and Primary Care Diagnostics20260—