510(k) Report

Devices descending from K130779

24 later devices reach Lvivo EF System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K180995Vscan ExtendGE Medical Systems Ultrasound and Primary Care Diagnostics2018107
+1K173780EchoMD Automated Ejection Fraction SoftwareBay Labs, Inc.201810—
+1K161382LVivo Software ApplicationDiacardio, Ltd.20160—
+1K143176UltraLinqUltralinq Healthcare Solutions, Inc.20150—
+2K220956Libby Echo:PrioDyad Medical, Inc.20221—
+2K210791Us2.v1Eko.Ai Pte Ltd. D/B/A Us2.Ai20213—
+2K202035Vscan AirGE Medical Systems Ultrasound and Primary Care Diagnostics20203—
+2K200621Caption Interpretation Automated Ejection Fraction SoftwareCaption Health202031
+2K193518KosmosEchoNous, Inc.20201—
+2K181934Vivid T8, Vivid T9GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC20183—
+3K252105Ligence HeartLigence Uab20250—
+3K250670EchoConfidence (USA)Mycardium AI Limited20250—
+3K241430EchoMeasureIcardio.Ai20240—
+3K234153EdgeLife Handheld Wireless Ultrasound System (E8200); EdgeLife Handheld Wireless…Edgelife Technologies, LLC20240—
+3K233676Us2.v2Eko.Ai Pte Ltd. D/B/A Us2.Ai20240—
+3K231301Vscan AirGE Medical Systems Ultrasound and Primary Care Diagnostics20231—
+3K210747Caption Interpretation Automated Ejection Fraction SoftwareCaption Health20222—
+3K212100KosmosEchoNous, Inc.202101
+3K200851Vivid T8, Vivid T9GE Medical Systems Ultrasound and Primary Care Diagnostics20202—
+4K253593Clarius Ejection Fraction AIClarius Mobile Health Corp.20260—
+4K250087Vscan AirGE Medical Systems Ultrasound and Primary Care Diagnostics20250—
+4K232331InVision Precision LVEF (LVEF)InVision Medical Technology Corporation20240—
+4K221147Vivid T8, Vivid T9GE Medical Systems Ultrasound and Primary Care Diagnostics20221—
+5K243628Vivid T9/Vivid T8GE Medical Systems Ultrasound and Primary Care Diagnostics20250—