510(k) Report

Devices descending from K111543

2 later devices reach Virtuoso (TM) System for Ihc HER2 (4B5) through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K140957Genasis Hipath Ihc FamilyApplied Spectral Imaging, Ltd.20150—
+1K131140Omnyx Idp for HER2 Manual ApplicationOmnyx, LLC20140—