510(k) Report

Devices descending from K042203

165 later devices reach Leonardo Syngo Cardiology Workstation through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K242781cvi42 Software ApplicationCircle Cardiovascular Imaging, Inc.20240—
+6K234141AISAP Cardio V1.0Aisap20240—
+6K232501AI Platform (AIP001)Exo, Inc.20231—
+6K230209Sonix HealthOntact Health Co., Ltd.20233—
+6K222970LVivo IQSDia Imaging Analysis, Ltd.20236—
+6K220940EchoPAC Software Only, EchoPAC Plug-inGE Medical Systems Ultrasound and Primary Care Diagnostics20222—
+6K212466LVivo SeamlessDia Imaging Analysis, Ltd.20211—
+6K200708Vivid iqGe Medical Systems Ultrasound And20203—
+6K200851Vivid T8, Vivid T9GE Medical Systems Ultrasound and Primary Care Diagnostics20202—
+6K200497Vivid S60N, Vivid S70NGE Medical Systems Ultrasound and Primary Care Diagnostics202042
+6K200274CariCloudCaristo Diagnostics20200—
+6K192437Arterys MICAArterys, Inc.20202—
+6K191798Versana ActiveGE Medical Systems Ultrasound and Primary Care Diagnostics20191—
+6K191792Versana BalanceGE Medical Systems Ultrasound and Primary Care Diagnostics20193—
+6K181685Vivid E80, Vivid E90, Vivid E95GE Medical Systems Ultrasound and Primary Care Diagnostics201813—
+6K163232Vitrea ViewVital Images, Inc.20177—
+6K171053syngo Dynamics Version VA30Siemens Healthcare GmbH20174—
+6K161061IMPAX Volume Viewing 4.0Agfa Healthcare N.V.20160—
+7K252007BlineSlideDeep Breathe, Inc.20250—
+7K251342EchoPAC Software Only / EchoPAC Plug-inGE Medical Systems Ultrasound and Primary Care Diagnostics20251—
+7K243684BrightHeart View ClassifierBrightheart20251—
+7K243331LVivo SeamlessDia Imaging Analysis, Ltd.20250—
+7K240645Sonix HealthOntact Health Co., Ltd.20240—
+7K240553LVivo Software ApplicationDia Imaging Analysis, Ltd.20242—
+7K240953AI Platform 2.0 (AIP002)Exo Imaging20241—
+7K240769LVivo IQSDia Imaging Analysis, Ltd.20240—
+7K221148Vivid iqGE Medical Systems Ultrasound & Primary Care Diagnostics, LLC20222—
+7K221147Vivid T8, Vivid T9GE Medical Systems Ultrasound and Primary Care Diagnostics20221—
+7K220832syngo Dynamics (Version VA40E)Siemens Medical Solutions USA, Inc.20223—
+7K220446Versana BalanceGE Medical Systems Ultrasound and Primary Care Diagnostics20221—
+7K203744Arterys MICAArterys, Inc.20221—
+7K211216Vivid S60N / Vivid S70NGE Medical Systems Ultrasound and Primary Care Diagnostics202132
+7K201768Voluson E10GE Healthcare20204—
+7K200743Vivid E80/ Vivid E90/ Vivid E95Ge Medical Systems Ultrasound And20207—
+7K200998Versana ActiveGE Medical Systems Ultrasound and Primary Care Diagnostics20200—
+7K190764SurgicalARMedivis, Inc.20196—
+8K261623EchoPAC Software Only / EchoPAC Plug-in (v211)GE Medical Systems Ultrasound and Primary Care Diagnostics20260—
+8K260217AI Platform 2.2 (AIP002)Exo Imaging20260—
+8K252539Tempus PixelArterys, Inc.20250—
+8K250913TINGSN FINDERS 2 Color Doppler Diagnostic Ultrasound SystemJiangsu Tingsn Technology Co., Ltd.20250—
+8K251456BrightHeart View ClassifierBrightheart20250—
+8K243862LVivo Software ApplicationDia Imaging Analysis, Ltd.20250—
+8K243235LVivo Software ApplicationDia Imaging Analysis, Ltd.20250—
+8K243628Vivid T9/Vivid T8GE Medical Systems Ultrasound and Primary Care Diagnostics20250—
+8K243620Vivid iqGE Medical Systems Ultrasound and Primary Care Diagnostics20250—
+8K230249IkshanaImmersivetouch20231—
+8K221870CarnaLife HoloMedapp S.A.20230—
+8K223407Versana EssentialGE Medical Systems Ultrasound and Primary Care Diagnostics20230—
+8K213215VSI HoloMedicineApoqlar GmbH20222—
+8K222428Syngo Dynamics (Version VA40F)Siemens Medical Solutions USA, Inc.20222—
+8K220619Vivid S60N, Vivid S70NGE Medical Systems Ultrasound and Primary Care Diagnostics202222
+8K220358Voluson Expert 22, Voluson Expert 20, Voluson Expert 18GE Medical Systems Ultrasound and Primary Care Diagnostics20223—
+8K202658Vivid E80/ Vivid E90/ Vivid E95GE Medical Systems Ultrasound and Primary Care Diagnostics20215—
+9K253486SKIA-Head (Model: SKIA-ST00)Skia, Inc.20260—
+9K251577Laia XRAugmented Reality Software S.L.20260—
+9K242551syngo Dynamics (Version VA41D)Siemens Healthcare GmbH20251—
+9K240094LumiNE US; LumiAugmedit B.V.20240—
+9K231965Voluson Expert 22, Voluson Expert 20, Voluson Expert 18GE Medical Systems Ultrasound and Primary Care Diagnostics20232—
+9K223832Vivid S60N, Vivid S70NGe Medical System Ultrasound and Primary Care Diagnostics202312
+9K220882Vivid E80, Vivid E90, Vivid E95Ge Medical Systems Ultrasound And20222—
+10K261313Vivid Explorer/Vivid Advanced/Vivid FocusGE Medical Systems Ultrasound and Primary Care Diagnostics20260—
+10K253689syngo Dynamics (VA41F)Siemens Healthcare GmbH20260—
+10K251169Vivid PioneerGE Medical Systems Ultrasound and Primary Care Diagnostics20250—
+10K242168Voluson Expert 18; Voluson Expert 20; Voluson Expert 22GE Medical Systems Ultrasound and Primary Care Diagnostics20241—
+11K252328Voluson Expert 18; Voluson Expert 20; Voluson Expert 22GE Medical Systems Ultrasound and Primary Care Diagnostics20250—