510(k) Report

Devices descending from K061602

5 later devices reach Duet System through their predicates, nearest generation first.

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