510(k) Report

Devices descending from K163065

15 later devices reach T3 Software through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K190273T3 Platform softwareEtiometry, Inc.201914—
+2K202306T3 Platform softwareEtiometry, Inc.202013—
+3K213230T3 Platform SoftwareEtiometry, Inc.202212—
+4K223578T3 Platform softwareEtiometry, Inc.20232—
+4K213423T3 Platform softwareEtiometry, Inc.20232—
+4K222463EchoGo Heart FailureUltromics Limited20227—
+5K251293CardioVisionIcardio.Ai20250—
+5K241479Etiometry Platform (DAV 5.4 RAE 9.2)Etiometry, Inc.20251—
+5K240860EchoGo Amyloidosis (1.0)Ultromics Limited20242—
+5K240013EchoGo Heart Failure (2.0)Ultromics Limited20240—
+5K223905Vivio® LVEDP SystemAvicena, LLC20230—
+5K231335Cleerly ISCHEMIACleerly, Inc.20230—
+6K254066Etiometry PlatformEtiometry, Inc.20260—
+6K250151Us2.caEko.Ai Pte Ltd. D/B/A Us2.Ai20250—
+6K243866InVision Precision Cardiac AmyloidInVision Medical Technology Corporation20250—