510(k) Report

Devices descending from K081140

22 later devices reach Visensia through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K152258T3 SoftwareEtiometry, Inc.201616—
+1K142512Personalized Physiology Analytics Engine softwareVgbio, Inc (Dba Physiq)20153—
+1K110953Visensia, Visensia with AlertObs Medical201117—
+2K183282Biovitals Analytics EngineBiofourmis Singapore Pte., Ltd.20192—
+2K163065T3 SoftwareEtiometry, Inc.201715—
+3K230386SpassageQSpass, Inc.20231—
+3K190273T3 Platform softwareEtiometry, Inc.201914—
+4K240558NavoycdsAlgodx AB20240—
+4K202306T3 Platform softwareEtiometry, Inc.202013—
+5K213230T3 Platform SoftwareEtiometry, Inc.202212—
+6K223578T3 Platform softwareEtiometry, Inc.20232—
+6K213423T3 Platform softwareEtiometry, Inc.20232—
+6K222463EchoGo Heart FailureUltromics Limited20227—
+7K251293CardioVisionIcardio.Ai20250—
+7K241479Etiometry Platform (DAV 5.4 RAE 9.2)Etiometry, Inc.20251—
+7K240860EchoGo Amyloidosis (1.0)Ultromics Limited20242—
+7K240013EchoGo Heart Failure (2.0)Ultromics Limited20240—
+7K223905Vivio® LVEDP SystemAvicena, LLC20230—
+7K231335Cleerly ISCHEMIACleerly, Inc.20230—
+8K254066Etiometry PlatformEtiometry, Inc.20260—
+8K250151Us2.caEko.Ai Pte Ltd. D/B/A Us2.Ai20250—
+8K243866InVision Precision Cardiac AmyloidInVision Medical Technology Corporation20250—