510(k) Report

Devices descending from K150122

56 later devices reach Tomtec-Arena TTA2 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K223322Argus Cognitive ReVISION SoftwareArgus Cognitive, Inc.20231—
+1K201632Tomtec-ArenaTomtec Imaging Systems GmbH202010—
+1K200974QLAB Advanced Quantification SoftwarePhilips Health Care202012—
+1K191171EchoGo CoreUltromics, Ltd.20193—
+1K170878Vivid S60N, Vivid S70NGE Medical Systems Ultrasound & Primary Care Diagnostics, LLC2017102
+1K170847EchoPAC Software Only, EchoPAC Plug-inGE Medical Systems Ultrasound and Primary Care Diagnostics20174—
+1K170823Vivid E80, Vivid E90, Vivid E95GE Medical Systems Ultrasound and Primary Care Diagnostics2017353
+2K251417ReVISION 2Argus Cognitive, Inc.20260—
+2K250670EchoConfidence (USA)Mycardium AI Limited20250—
+2K223422Emory Cardiac Toolbox 4.3Syntermed20230—
+2K212376Caas QardiaPie Medical Imaging BV20220—
+2K213544Tomtec-ArenaTomtec Imaging Systems GmbH20226—
+2K213275EchoGo Core (2.0)Ultromics Limited20211—
+2K200603AAA ModelPhilips Ultrasound, Inc.20200—
+2K200852EchoPAC Software Only, EchoPAC Plug-InGE Medical Systems Ultrasound and Primary Care Diagnostics20203—
+2K181727Vivid iqGE Medical Systems Ultrasound and Primary Care Diagnostics20189—
+2K181934Vivid T8, Vivid T9GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC20183—
+2K182450Vivid S60N, Vivid S70NGE Medical Systems Ultrasound and Primary Care Diagnostics201892
+2K173341Vivid E80, Vivid E90, Vivid E95GE Medical Systems2017203
+3K2503303mensio WorkstationPie Medical Imaging BV202501
+3K241659Ultrasound Workspace (UWS 6.0)Philips Ultrasound, LLC20250—
+3K234141AISAP Cardio V1.0Aisap20240—
+3K230209Sonix HealthOntact Health Co., Ltd.20233—
+3K220940EchoPAC Software Only, EchoPAC Plug-inGE Medical Systems Ultrasound and Primary Care Diagnostics20222—
+3K200708Vivid iqGe Medical Systems Ultrasound And20203—
+3K200851Vivid T8, Vivid T9GE Medical Systems Ultrasound and Primary Care Diagnostics20202—
+3K200497Vivid S60N, Vivid S70NGE Medical Systems Ultrasound and Primary Care Diagnostics202042
+3K191798Versana ActiveGE Medical Systems Ultrasound and Primary Care Diagnostics20191—
+3K191792Versana BalanceGE Medical Systems Ultrasound and Primary Care Diagnostics20193—
+3K181685Vivid E80, Vivid E90, Vivid E95GE Medical Systems Ultrasound and Primary Care Diagnostics201813—
+4K251342EchoPAC Software Only / EchoPAC Plug-inGE Medical Systems Ultrasound and Primary Care Diagnostics20251—
+4K243684BrightHeart View ClassifierBrightheart20251—
+4K240645Sonix HealthOntact Health Co., Ltd.20240—
+4K221148Vivid iqGE Medical Systems Ultrasound & Primary Care Diagnostics, LLC20222—
+4K221147Vivid T8, Vivid T9GE Medical Systems Ultrasound and Primary Care Diagnostics20221—
+4K220446Versana BalanceGE Medical Systems Ultrasound and Primary Care Diagnostics20221—
+4K211216Vivid S60N / Vivid S70NGE Medical Systems Ultrasound and Primary Care Diagnostics202132
+4K201768Voluson E10GE Healthcare20204—
+4K200743Vivid E80/ Vivid E90/ Vivid E95Ge Medical Systems Ultrasound And20207—
+4K200998Versana ActiveGE Medical Systems Ultrasound and Primary Care Diagnostics20200—
+5K261623EchoPAC Software Only / EchoPAC Plug-in (v211)GE Medical Systems Ultrasound and Primary Care Diagnostics20260—
+5K250913TINGSN FINDERS 2 Color Doppler Diagnostic Ultrasound SystemJiangsu Tingsn Technology Co., Ltd.20250—
+5K251456BrightHeart View ClassifierBrightheart20250—
+5K243628Vivid T9/Vivid T8GE Medical Systems Ultrasound and Primary Care Diagnostics20250—
+5K243620Vivid iqGE Medical Systems Ultrasound and Primary Care Diagnostics20250—
+5K223407Versana EssentialGE Medical Systems Ultrasound and Primary Care Diagnostics20230—
+5K220619Vivid S60N, Vivid S70NGE Medical Systems Ultrasound and Primary Care Diagnostics202222
+5K220358Voluson Expert 22, Voluson Expert 20, Voluson Expert 18GE Medical Systems Ultrasound and Primary Care Diagnostics20223—
+5K202658Vivid E80/ Vivid E90/ Vivid E95GE Medical Systems Ultrasound and Primary Care Diagnostics20215—
+6K231965Voluson Expert 22, Voluson Expert 20, Voluson Expert 18GE Medical Systems Ultrasound and Primary Care Diagnostics20232—
+6K223832Vivid S60N, Vivid S70NGe Medical System Ultrasound and Primary Care Diagnostics202312
+6K220882Vivid E80, Vivid E90, Vivid E95Ge Medical Systems Ultrasound And20222—
+7K261313Vivid Explorer/Vivid Advanced/Vivid FocusGE Medical Systems Ultrasound and Primary Care Diagnostics20260—
+7K251169Vivid PioneerGE Medical Systems Ultrasound and Primary Care Diagnostics20250—
+7K242168Voluson Expert 18; Voluson Expert 20; Voluson Expert 22GE Medical Systems Ultrasound and Primary Care Diagnostics20241—
+8K252328Voluson Expert 18; Voluson Expert 20; Voluson Expert 22GE Medical Systems Ultrasound and Primary Care Diagnostics20250—