510(k) Report

Devices descending from K053520

8 later devices reach Ventana Image Analysis System, Model KI-67 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K092333Pathiam System with Iscan for P53 and KI-67Bioimagene, Inc.20107—
+2K111872Virtuoso System for Ihc P53 (DO-7)Ventana Medical Systems, Inc.20121—
+2K111755Virtuoso System for Ihc KI-67 (30-9)Ventana Medical Systems, Inc.20122—
+2K111543Virtuoso (TM) System for Ihc HER2 (4B5)Ventana Medical Systems, Inc.20112—
+3K140957Genasis Hipath Ihc FamilyApplied Spectral Imaging, Ltd.20150—
+3K131140Omnyx Idp for HER2 Manual ApplicationOmnyx, LLC20140—
+3K121033Virtuoso System for Ihc KI-67 (30-9)Ventana Medical Systems, Inc.20130—
+3K121350Virtuso System for Ihc (DO-7)Ventana Medical Systems, Inc.20120—