510(k) Report

Devices descending from K960043

145 later devices reach Kodak Cardiology Digital Archive & Review System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+9K200708Vivid iqGe Medical Systems Ultrasound And20203—
+9K200851Vivid T8, Vivid T9GE Medical Systems Ultrasound and Primary Care Diagnostics20202—
+9K200497Vivid S60N, Vivid S70NGE Medical Systems Ultrasound and Primary Care Diagnostics202042
+9K191798Versana ActiveGE Medical Systems Ultrasound and Primary Care Diagnostics20191—
+9K191792Versana BalanceGE Medical Systems Ultrasound and Primary Care Diagnostics20193—
+9K181685Vivid E80, Vivid E90, Vivid E95GE Medical Systems Ultrasound and Primary Care Diagnostics201813—
+9K171053syngo Dynamics Version VA30Siemens Healthcare GmbH20174—
+10K252007BlineSlideDeep Breathe, Inc.20250—
+10K251342EchoPAC Software Only / EchoPAC Plug-inGE Medical Systems Ultrasound and Primary Care Diagnostics20251—
+10K243684BrightHeart View ClassifierBrightheart20251—
+10K243331LVivo SeamlessDia Imaging Analysis, Ltd.20250—
+10K240645Sonix HealthOntact Health Co., Ltd.20240—
+10K240553LVivo Software ApplicationDia Imaging Analysis, Ltd.20242—
+10K240953AI Platform 2.0 (AIP002)Exo Imaging20241—
+10K240769LVivo IQSDia Imaging Analysis, Ltd.20240—
+10K221148Vivid iqGE Medical Systems Ultrasound & Primary Care Diagnostics, LLC20222—
+10K221147Vivid T8, Vivid T9GE Medical Systems Ultrasound and Primary Care Diagnostics20221—
+10K220832syngo Dynamics (Version VA40E)Siemens Medical Solutions USA, Inc.20223—
+10K220446Versana BalanceGE Medical Systems Ultrasound and Primary Care Diagnostics20221—
+10K211216Vivid S60N / Vivid S70NGE Medical Systems Ultrasound and Primary Care Diagnostics202132
+10K201768Voluson E10GE Healthcare20204—
+10K200743Vivid E80/ Vivid E90/ Vivid E95Ge Medical Systems Ultrasound And20207—
+10K200998Versana ActiveGE Medical Systems Ultrasound and Primary Care Diagnostics20200—
+11K261623EchoPAC Software Only / EchoPAC Plug-in (v211)GE Medical Systems Ultrasound and Primary Care Diagnostics20260—
+11K260217AI Platform 2.2 (AIP002)Exo Imaging20260—
+11K250913TINGSN FINDERS 2 Color Doppler Diagnostic Ultrasound SystemJiangsu Tingsn Technology Co., Ltd.20250—
+11K251456BrightHeart View ClassifierBrightheart20250—
+11K243862LVivo Software ApplicationDia Imaging Analysis, Ltd.20250—
+11K243235LVivo Software ApplicationDia Imaging Analysis, Ltd.20250—
+11K243628Vivid T9/Vivid T8GE Medical Systems Ultrasound and Primary Care Diagnostics20250—
+11K243620Vivid iqGE Medical Systems Ultrasound and Primary Care Diagnostics20250—
+11K223407Versana EssentialGE Medical Systems Ultrasound and Primary Care Diagnostics20230—
+11K222428Syngo Dynamics (Version VA40F)Siemens Medical Solutions USA, Inc.20222—
+11K220619Vivid S60N, Vivid S70NGE Medical Systems Ultrasound and Primary Care Diagnostics202222
+11K220358Voluson Expert 22, Voluson Expert 20, Voluson Expert 18GE Medical Systems Ultrasound and Primary Care Diagnostics20223—
+11K202658Vivid E80/ Vivid E90/ Vivid E95GE Medical Systems Ultrasound and Primary Care Diagnostics20215—
+12K242551syngo Dynamics (Version VA41D)Siemens Healthcare GmbH20251—
+12K231965Voluson Expert 22, Voluson Expert 20, Voluson Expert 18GE Medical Systems Ultrasound and Primary Care Diagnostics20232—
+12K223832Vivid S60N, Vivid S70NGe Medical System Ultrasound and Primary Care Diagnostics202312
+12K220882Vivid E80, Vivid E90, Vivid E95Ge Medical Systems Ultrasound And20222—
+13K261313Vivid Explorer/Vivid Advanced/Vivid FocusGE Medical Systems Ultrasound and Primary Care Diagnostics20260—
+13K253689syngo Dynamics (VA41F)Siemens Healthcare GmbH20260—
+13K251169Vivid PioneerGE Medical Systems Ultrasound and Primary Care Diagnostics20250—
+13K242168Voluson Expert 18; Voluson Expert 20; Voluson Expert 22GE Medical Systems Ultrasound and Primary Care Diagnostics20241—
+14K252328Voluson Expert 18; Voluson Expert 20; Voluson Expert 22GE Medical Systems Ultrasound and Primary Care Diagnostics20250—