510(k) Report

Devices descending from K170434

3 later devices reach Enterprise Imaging XERO Viewer 8.1 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K252199AGFA HealthCare Enterprise ImagingAgfa Healthcare N.V.20250—
+1K200822BraidBraid.Health20201—
+2K231385Rology Teleradiology Platform (v.1.22.1103)Rology, Inc.20230—