510(k) Report

Devices descending from K152258

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K163065T3 SoftwareEtiometry, Inc.201715—
+2K190273T3 Platform softwareEtiometry, Inc.201914—
+3K202306T3 Platform softwareEtiometry, Inc.202013—
+4K213230T3 Platform SoftwareEtiometry, Inc.202212—
+5K223578T3 Platform softwareEtiometry, Inc.20232—
+5K213423T3 Platform softwareEtiometry, Inc.20232—
+5K222463EchoGo Heart FailureUltromics Limited20227—
+6K251293CardioVisionIcardio.Ai20250—
+6K241479Etiometry Platform (DAV 5.4 RAE 9.2)Etiometry, Inc.20251—
+6K240860EchoGo Amyloidosis (1.0)Ultromics Limited20242—
+6K240013EchoGo Heart Failure (2.0)Ultromics Limited20240—
+6K223905Vivio® LVEDP SystemAvicena, LLC20230—
+6K231335Cleerly ISCHEMIACleerly, Inc.20230—
+7K254066Etiometry PlatformEtiometry, Inc.20260—
+7K250151Us2.caEko.Ai Pte Ltd. D/B/A Us2.Ai20250—
+7K243866InVision Precision Cardiac AmyloidInVision Medical Technology Corporation20250—