510(k) Report

Devices descending from K080564

3 later devices reach Scanscope XT System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+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—