510(k) Report

Devices descending from DEN190040

7 later devices reach Caption Guidance through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K260338ThinkSono GuidanceThinkSono GmbH20260—
+1K242807HeartFocus (V.1.1.1)Deski20251—
+1K223347UltraSight AI GuidanceUltrasight, Inc.20230—
+1K200755Caption GuidanceCaption Health20202—
+2K260780HeartFocusDeski20260—
+2K201992Caption GuidanceCaption Health20201—
+3K243065Cardiac GuidanceCaption Health, Inc.20250—