510(k) Report

Devices descending from K130796

25 later devices reach Vital Sync Informatics Manager & Virtual Patient Monitoring Platform through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K132604Vital Sync Informatics Manager & Virtual Patient Monitoring PlatformCovidien2013242
+2K143304Sickbay Clinical PlatformMedical Informatics Corp20150—
+2K142732T3 SoftwareEtiometry, Inc.201518—
+2K140339Vital Sync Informatics Manager & Virtual Patient Monitoring PlatformCovidien2014222
+3K171056WAVE Clinical PlatformExcel Medical Electronics, LLC20181—
+3K160718Vital Sync Informatics Manager & Virtual Patient Monitoring PlatformCovidien201601
+3K152258T3 SoftwareEtiometry, Inc.201616—
+3K151715T3 SoftwareEtiometry, Inc.201517—
+4K250135WAVE Clinical Platform (2.0.000)Baxter Healthcare Corp/ Excel Medical20260—
+4K163065T3 SoftwareEtiometry, Inc.201715—
+5K190273T3 Platform softwareEtiometry, Inc.201914—
+6K202306T3 Platform softwareEtiometry, Inc.202013—
+7K213230T3 Platform SoftwareEtiometry, Inc.202212—
+8K223578T3 Platform softwareEtiometry, Inc.20232—
+8K213423T3 Platform softwareEtiometry, Inc.20232—
+8K222463EchoGo Heart FailureUltromics Limited20227—
+9K251293CardioVisionIcardio.Ai20250—
+9K241479Etiometry Platform (DAV 5.4 RAE 9.2)Etiometry, Inc.20251—
+9K240860EchoGo Amyloidosis (1.0)Ultromics Limited20242—
+9K240013EchoGo Heart Failure (2.0)Ultromics Limited20240—
+9K223905Vivio® LVEDP SystemAvicena, LLC20230—
+9K231335Cleerly ISCHEMIACleerly, Inc.20230—
+10K254066Etiometry PlatformEtiometry, Inc.20260—
+10K250151Us2.caEko.Ai Pte Ltd. D/B/A Us2.Ai20250—
+10K243866InVision Precision Cardiac AmyloidInVision Medical Technology Corporation20250—