510(k) Report

Devices descending from K122133

35 later devices reach Airstrip Remote Patient Monitoring (RPM) Remote Data Viewing through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K230214Huma RPM (RPM)Medopad, Inc.20230—
+1K171361Bettercare Platform - Advanced Web ClientBetter Care S.L.20180—
+1K133534Mckesson Cardiology Ecg MobileMckesson Israel, Ltd.20146—
+1K130796Vital Sync Informatics Manager & Virtual Patient Monitoring PlatformCovidien2013252
+2K181720Epiphany Cardio Server MobileEpiphany Healthcare, LLC20180—
+2K151774CARESTREAM Vue MotionCarestream Health, Inc.201541
+2K132604Vital Sync Informatics Manager & Virtual Patient Monitoring PlatformCovidien2013242
+3K170434Enterprise Imaging XERO Viewer 8.1Agfa Healthcare N.V.201732
+3K143304Sickbay Clinical PlatformMedical Informatics Corp20150—
+3K142732T3 SoftwareEtiometry, Inc.201518—
+3K140339Vital Sync Informatics Manager & Virtual Patient Monitoring PlatformCovidien2014222
+4K252199AGFA HealthCare Enterprise ImagingAgfa Healthcare N.V.20250—
+4K200822BraidBraid.Health20201—
+4K171056WAVE Clinical PlatformExcel Medical Electronics, LLC20181—
+4K160718Vital Sync Informatics Manager & Virtual Patient Monitoring PlatformCovidien201601
+4K152258T3 SoftwareEtiometry, Inc.201616—
+4K151715T3 SoftwareEtiometry, Inc.201517—
+5K250135WAVE Clinical Platform (2.0.000)Baxter Healthcare Corp/ Excel Medical20260—
+5K231385Rology Teleradiology Platform (v.1.22.1103)Rology, Inc.20230—
+5K163065T3 SoftwareEtiometry, Inc.201715—
+6K190273T3 Platform softwareEtiometry, Inc.201914—
+7K202306T3 Platform softwareEtiometry, Inc.202013—
+8K213230T3 Platform SoftwareEtiometry, Inc.202212—
+9K223578T3 Platform softwareEtiometry, Inc.20232—
+9K213423T3 Platform softwareEtiometry, Inc.20232—
+9K222463EchoGo Heart FailureUltromics Limited20227—
+10K251293CardioVisionIcardio.Ai20250—
+10K241479Etiometry Platform (DAV 5.4 RAE 9.2)Etiometry, Inc.20251—
+10K240860EchoGo Amyloidosis (1.0)Ultromics Limited20242—
+10K240013EchoGo Heart Failure (2.0)Ultromics Limited20240—
+10K223905Vivio® LVEDP SystemAvicena, LLC20230—
+10K231335Cleerly ISCHEMIACleerly, Inc.20230—
+11K254066Etiometry PlatformEtiometry, Inc.20260—
+11K250151Us2.caEko.Ai Pte Ltd. D/B/A Us2.Ai20250—
+11K243866InVision Precision Cardiac AmyloidInVision Medical Technology Corporation20250—