510(k) Report

Devices descending from K992607

28 later devices reach Sonicaid System 8002 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K081140VisensiaObs Medical200822—
+1K053112BiosignOxford Biosignals Limited20068—
+2K152258T3 SoftwareEtiometry, Inc.201616—
+2K142512Personalized Physiology Analytics Engine softwareVgbio, Inc (Dba Physiq)20153—
+2K124038Bedside Paediatric Early Warning System (Bedsidepews)Bedside Clinical Systems, Inc.20132—
+2K110953Visensia, Visensia with AlertObs Medical201117—
+2K071606Biosign Central StationObs Medical20070—
+3K183282Biovitals Analytics EngineBiofourmis Singapore Pte., Ltd.20192—
+3K172959PeraServer and PeraTrendPerahealth, Inc.20181—
+3K163065T3 SoftwareEtiometry, Inc.201715—
+4K230386SpassageQSpass, Inc.20231—
+4K190273T3 Platform softwareEtiometry, Inc.201914—
+4K183370PeraMobile and PeraWatchPerahealth, Inc.20190—
+5K240558NavoycdsAlgodx AB20240—
+5K202306T3 Platform softwareEtiometry, Inc.202013—
+6K213230T3 Platform SoftwareEtiometry, Inc.202212—
+7K223578T3 Platform softwareEtiometry, Inc.20232—
+7K213423T3 Platform softwareEtiometry, Inc.20232—
+7K222463EchoGo Heart FailureUltromics Limited20227—
+8K251293CardioVisionIcardio.Ai20250—
+8K241479Etiometry Platform (DAV 5.4 RAE 9.2)Etiometry, Inc.20251—
+8K240860EchoGo Amyloidosis (1.0)Ultromics Limited20242—
+8K240013EchoGo Heart Failure (2.0)Ultromics Limited20240—
+8K223905Vivio® LVEDP SystemAvicena, LLC20230—
+8K231335Cleerly ISCHEMIACleerly, Inc.20230—
+9K254066Etiometry PlatformEtiometry, Inc.20260—
+9K250151Us2.caEko.Ai Pte Ltd. D/B/A Us2.Ai20250—
+9K243866InVision Precision Cardiac AmyloidInVision Medical Technology Corporation20250—