510(k) Report

Devices descending from K043519

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K061602Duet SystemBioview, Ltd.20075—
+2K130775Duet SystemBioview, Ltd.20140—
+2K101291Scanview HER2/Neu Fish SystemApplied Spectral Imaging, Ltd.20102—
+2K080909Iconoscope Oncofish HER2 Test System, Model 2000Ikonisys, Inc.20080—
+3K110345Scanview SystemApplied Spectral Imaging20111—
+4K122554Genasis Scanview SystemApplied Spectral Imaging, Ltd.20130—