510(k) Report

Devices descending from K092333

7 later devices reach Pathiam System with Iscan for P53 and KI-67 through their predicates, nearest generation first.

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