510(k) Report

Devices descending from K032113

13 later devices reach Acis (Automated Cellular Imaging System) through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K080564Scanscope XT SystemAperio Technologies20093—
+1K071671Scanscope XT SystemAperio Technologies20074—
+1K071128Scanscope XT SystemAperio Technologies20072—
+1K062756Pathiam Imaging Software for HER2/NeuBioimagene, Inc.20071—
+2K141109Aperio Epathology Eihc Ivd SystemLeica Biosystems Imaging, Inc.201411
+2K131140Omnyx Idp for HER2 Manual ApplicationOmnyx, LLC20140—
+2K130021Philips Herceptest Digital ScorePhilips Medical Systems Nederland B.V.20130—
+2K111914Virtual Slide System, Olympus VS800 SystemOlympus America Inc. / Scientific Equipment Group20121—
+2K111543Virtuoso (TM) System for Ihc HER2 (4B5)Ventana Medical Systems, Inc.20112—
+2K080910Pathiam System for HER2/Neu Immunohistochemistry Reagents & KitsBioimagene, Inc.20090—
+2K080254Scanscope XT SystemAperio Technologies20080—
+3K260755OptraSCAN SystemOptrascan, Inc.20260—
+3K140957Genasis Hipath Ihc FamilyApplied Spectral Imaging, Ltd.20150—