510(k) Report

Devices descending from K031715

4 later devices reach Ariol Her-2/Neu Ihc through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K080564Scanscope XT SystemAperio Technologies20093—
+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—