510(k) Report

Devices descending from K123002

19 later devices reach Vital Sync System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K142732T3 SoftwareEtiometry, Inc.201518—
+2K152258T3 SoftwareEtiometry, Inc.201616—
+2K151715T3 SoftwareEtiometry, Inc.201517—
+3K163065T3 SoftwareEtiometry, Inc.201715—
+4K190273T3 Platform softwareEtiometry, Inc.201914—
+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—