510(k) Report

Devices descending from K040227

908 later devices reach Qlab Quantification Software through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+10K250177EPIQ Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC20252—
+10K242681NUSONO Handheld Ultrasound Scanner (NUSONO-C35); NUSONO Handheld Ultrasound Scanner…Nurodata, Inc.20251—
+10K242444HERA W10 Diagnostic Ultrasound System; HERA W9 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20240—
+10K240645Sonix HealthOntact Health Co., Ltd.20240—
+10K242496Portable Liver Elastography Ultrasound Diagnostic System (Liverscan C)Eieling Technology (Shenzhen) Limited20240—
+10K242231Resona A10S, Resona A20 Pro, Resona A20T, Resona A20S, Resona A20W, Resona A20, Resona…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20241—
+10K241201TEX20/TEX20 Pro/TEX20S/TEX20T/TEX20 Exp/TEX20 Elite/TEX10/TEX10 Pro/TEX10S/TEX10T/TEX10…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20240—
+10K241161Ultrasound Imaging System (LK128L); Ultrasound Imaging System (LK128LH); Ultrasound…Leltek, Inc.20243—
+10K233112HM70 EVO Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20232—
+10K233545EPIQ Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC202301
+10K231685TE Air Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.20232—
+10K231772V8/H8 Diagnostic Ultrasound System, V7/H7 Diagnostic Ultrasound System, V6/H6 Diagnostic…Samsung Medison Co., Ltd.20238—
+10K232459VelacurSonic Incytes20232—
+10K220940EchoPAC Software Only, EchoPAC Plug-inGE Medical Systems Ultrasound and Primary Care Diagnostics20222—
+10K221148Vivid iqGE Medical Systems Ultrasound & Primary Care Diagnostics, LLC20222—
+10K221147Vivid T8, Vivid T9GE Medical Systems Ultrasound and Primary Care Diagnostics20221—
+10K220851VenueGE Medical Systems20223—
+10K220358Voluson Expert 22, Voluson Expert 20, Voluson Expert 18GE Medical Systems Ultrasound and Primary Care Diagnostics20223—
+10K220446Versana BalanceGE Medical Systems Ultrasound and Primary Care Diagnostics20221—
+10K210438Versana PremierGE Medical Systems Ultrasound and Primary Care Diagnostics20211—
+10K211488Logiq E10GE Healthcare202111—
+10K211524LOGIQ E10s, LOGIQ FortisGE Healthcare20218—
+10K211216Vivid S60N / Vivid S70NGE Medical Systems Ultrasound and Primary Care Diagnostics202132
+10K203345MULTIX ImpactSiemens Medical Solutions USA, Inc.20215—
+10K203340MULTIX Impact CSiemens Medical Solutions USA, Inc.20213—
+10K203137Venue FitGE Medical Systems Ultrasound and Primary Care Diagnostics202051
+10K202233Venue GoGE Medical Systems Ultrasound and Primary Care Diagnostics202042
+10K200743Vivid E80/ Vivid E90/ Vivid E95Ge Medical Systems Ultrasound And20207—
+10K200998Versana ActiveGE Medical Systems Ultrasound and Primary Care Diagnostics20200—
+10K200917Azurion R2.1Philips Medical Systems Nederland B.V.20204Class I
+10K191663Aplio a550, Aplio a450 and Aplio a, Diagnostic Ultrasound System, V4.0Canon Medical Systems Corporation20193—
+10K181830Azurion R2.0Philips Medical Systems Nederland B.V.2018542
+10K171766Acuson SC2000 Diagnostic Ultrasound SystemSiemens Medi Cal Solutions, Inc.201720—
+11K262311Alturion Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC20260—
+11K261288Handheld Ultrasound ScannerImgfax CO., LTD.20260—
+11K260844ACUSON Sequoia Diagnostic Ultrasound System;ACUSON Sequoia Select Diagnostic Ultrasound…Siemens Medical Solutions USA, Inc.20260—
+11K252709Wireless Probe Type Ultrasound ScannerXuzhou Yongkang Electronic Science Technology Co., Ltd.20260—
+11K254099EVO Q30 Diagnostic Ultrasound System; EVO Q20 Diagnostic Ultrasound System; EVO Q10…Samsung Medison Co., Ltd.20261—
+11K253049Resona A10S, Resona A20 Pro, Resona A20T, Resona A20S, Resona A20W, Resona A20, Resona…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20260—
+11K253597Aplio beyond and Aplio me Software V2.0 Diagnostic Ultrasound SystemCanon Medical Systems Corporation20260—
+11K252074Aplio i900, Aplio i800 and Aplio i700 Software V9.0 Diagnostic Ultrasound SystemCanon Medical Systems Corporation20250—
+11K251827Azurion R3.1Philips Medical Systems B.V.20251—
+11K251651EPIQ Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC20251—
+11K250913TINGSN FINDERS 2 Color Doppler Diagnostic Ultrasound SystemJiangsu Tingsn Technology Co., Ltd.20250—
+11K251342EchoPAC Software Only / EchoPAC Plug-inGE Medical Systems Ultrasound and Primary Care Diagnostics20251—
+11K251456BrightHeart View ClassifierBrightheart20250—
+11K243226Ultrasound Imaging System (LU700 Series); Ultrasound Imaging System (128 Series)…Leltek, Inc.20251—
+11K243376uAngio AVIVA CXShanghai United Imaging Healthcare Co., Ltd.20251—
+11K243628Vivid T9/Vivid T8GE Medical Systems Ultrasound and Primary Care Diagnostics20250—
+11K243620Vivid iqGE Medical Systems Ultrasound and Primary Care Diagnostics20250—
+11K242168Voluson Expert 18; Voluson Expert 20; Voluson Expert 22GE Medical Systems Ultrasound and Primary Care Diagnostics20241—
+11K242005Versana Premier; Versana Premier Lotus; LOGIQ FGE Medical Systems Ultrasound and Primary Care Diagnostics202402
+11K233977VelacurSonic Incytes20241—
+11K240906TE Air Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.20241—
+11K240631V8/XV8/XH8, V7/XV7/XH7, V6/XV6/XH6 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20247—
+11K240111VenueGE Medical Systems Ultrasound and Primary Care Diagnostics20242—
+11K232381LOGIQ TotusGE Medical Systems Ultrasound and Primary Care Diagnostics20231—
+11K231966Logiq E10GE Medical Systems Ultrasound and Primary Care Diagnostics20235—
+11K231989LOGIQ E10s, LOGIQ FortisGe Medical Systems Ultrasound and Primary Care Diagnostic,20235—
+11K231965Voluson Expert 22, Voluson Expert 20, Voluson Expert 18GE Medical Systems Ultrasound and Primary Care Diagnostics20232—
+11K223407Versana EssentialGE Medical Systems Ultrasound and Primary Care Diagnostics20230—
+11K220619Vivid S60N, Vivid S70NGE Medical Systems Ultrasound and Primary Care Diagnostics202222
+11K220848Venue FitGE Medical Systems202241
+11K220800Venue GoGE Medical Systems Ultrasound and Primary Care Diagnostics202232
+11K220919MULTIX Impact ESiemens Medical Solutions USA, Inc.20222—
+11K213700MULTIX Impact, MULTIX Impact CSiemens Medical Solutions USA, Inc.20212—
+11K202658Vivid E80/ Vivid E90/ Vivid E95GE Medical Systems Ultrasound and Primary Care Diagnostics20215—
+11K202364Aplio a550, Aplio a450, Aplio a, Diagnostic Ultrasound System, Software V5.1Canon Medical Systems Corporation20201—
+11K181098ACUSON SC2000 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.201819—
+12K263182EVO X30 Diagnostic Ultrasound System; EVO X20 Diagnostic Ultrasound System; EVO X10…Samsung Medison Co., Ltd.20260—
+12K261623EchoPAC Software Only / EchoPAC Plug-in (v211)GE Medical Systems Ultrasound and Primary Care Diagnostics20260—
+12K260488MULTIX Impact; MULTIX Impact CSiemens Medical Solutions USA, Inc.20260—
+12K253726uAngio AVIVA CXShanghai United Imaging Healthcare Co., Ltd.20260—
+12K261211Philips EPIQ Series Diagnostic Ultrasound System; Philips Affiniti Series Diagnostic…Philips Ultrasound, LLC20260—
+12K253720uSONIQUE Nova, uSONIQUE Nova Elite, uSONIQUE Vita, uSONIQUE Vita Elite, uSONIQUE Grace…Wuhan United Imaging Healthcare Co.,Ltd20260—
+12K253716uSONIQUE Genesis, uSONIQUE Genesis Pro, uSONIQUE Genesis Elite, uSONIQUE Genesis Super…Wuhan United Imaging Healthcare Co.,Ltd20260—
+12K261132Healium Intelliscan LX192LCHealium Intelliscan Corporation20260—
+12K254186Azurion R3.1Philips Medical Systems B.V.20260—
+12K253370LOGIQ TotusGE Medical Systems Ultrasound and Primary Care Diagnostics20260—
+12K253366LOGIQ FortisGE Medical Systems Ultrasound and Primary Care Diagnostics20262—
+12K252328Voluson Expert 18; Voluson Expert 20; Voluson Expert 22GE Medical Systems Ultrasound and Primary Care Diagnostics20250—
+12K251985Logiq E10GE Medical Systems Ultrasound and Primary Care Diagnostics20250—
+12K251963LOGIQ E10sGE Medical Systems Ultrasound and Primary Care Diagnostics20250—
+12K251322Venue; Venue Go; Venue Fit; Venue SprintGE Medical Systems Ultrasound and Primary Care Diagnostics20251—
+12K251728Velacur One (LI-1100)Sonic Incytes Medical Corp20250—
+12K250024TE Air Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.20250—
+12K243702V8 Diagnostic Ultrasound System; cV8 Diagnostic Ultrasound System; V7 Diagnostic…Samsung Medison Co., Ltd.20254—
+12K242499Digital Radiography X-ray System (SONTU100-RAD (E) , SONTU300-Mars (E))Shenzhen Sontu Medical Imaging Equipment Co., Ltd.20250—
+12K240676ULTIMUS Series Ultrasound Diagnostic SystemVinno Technology (Suzhou) Co.,Ltd20240—
+12K242511V5 Diagnostic Ultrasound System, H5 Diagnostic Ultrasound System, XV5 Diagnostic…Samsung Medison Co., Ltd.20240—
+12K241971HERA Z20, R20, HERA Z30, R30 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20241—
+12K241029SpineUs™ SystemVerdure Imaging20240—
+12K240053Venue GoGE Medical Systems Ultrasound and Primary Care Diagnostics202421
+12K240206Venue SprintGE Medical Systems Ultrasound and Primary Care Diagnostics20242—
+12K234106Venue FitGE Medical Systems Ultrasound and Primary Care Diagnostics202421
+12K233532MULTIX Impact ESiemens Medical Solutions20230—
+12K223832Vivid S60N, Vivid S70NGe Medical System Ultrasound and Primary Care Diagnostics202312
+12K220882Vivid E80, Vivid E90, Vivid E95Ge Medical Systems Ultrasound And20222—
+12K212960Aplio a550, Aplio a450, and Aplio a, Diagnostic Ultrasound System, Software V6.5Canon Medical Systems Corporation202201
+12K200585Acuson SC2000 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.20208—