510(k) Report

Devices descending from K121916

5 later devices reach Intuition through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K200274CariCloudCaristo Diagnostics20200—
+1K191585iNtuition-Structural Heart ModuleTerarecon,Inc.20192—
+1K161061IMPAX Volume Viewing 4.0Agfa Healthcare N.V.20160—
+2K250337AiORTA - PlanViTAA Medical Solutions, Inc.20251—
+3K254207AiORTA - Plan v2.0ViTAA Medical Solutions, Inc.20260—