510(k) Report

Devices descending from K051325

23 later devices reach Webpax, Model 200 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K152949WebPAXHeart Imaging Technologies, LLC20160—
+1K092915Cedara Webaccess, Model: 2.4Cedara Software Corp.2010214
+2K182290IBM iConnect AccessMerge Healthcare Incorporated20183—
+2K111892Vitreaview Software 6.1Vital Images, Inc.201116—
+3K203104IBM iConnect AccessMerge Healthcare Incorporated20212—
+3K122136VitreaviewVital Images, Inc.201215—
+4K254237Cci Pacs Viewer (Pacs-US-001)CliniComp, Intl.20260—
+4K250301Merge Universal Viewer (MUV)Merge Healthcare Incorporated20250—
+4K150738VitreaViewVital Images, Inc.20158—
+4K121916IntuitionTerarecon,Inc.201351
+5K200274CariCloudCaristo Diagnostics20200—
+5K191585iNtuition-Structural Heart ModuleTerarecon,Inc.20192—
+5K163232Vitrea ViewVital Images, Inc.20177—
+5K161061IMPAX Volume Viewing 4.0Agfa Healthcare N.V.20160—
+6K250337AiORTA - PlanViTAA Medical Solutions, Inc.20251—
+6K190764SurgicalARMedivis, Inc.20196—
+7K254207AiORTA - Plan v2.0ViTAA Medical Solutions, Inc.20260—
+7K230249IkshanaImmersivetouch20231—
+7K221870CarnaLife HoloMedapp S.A.20230—
+7K213215VSI HoloMedicineApoqlar GmbH20222—
+8K253486SKIA-Head (Model: SKIA-ST00)Skia, Inc.20260—
+8K251577Laia XRAugmented Reality Software S.L.20260—
+8K240094LumiNE US; LumiAugmedit B.V.20240—