510(k) Report

Devices descending from K033982

8 later devices reach Modification to Vysis Urovysion Bladder Cancer Recurrence Test through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K050840Modification to Duet SystemBioview, Ltd.20057—
+2K130775Duet SystemBioview, Ltd.20140—
+2K110345Scanview SystemApplied Spectral Imaging20111—
+2K080909Iconoscope Oncofish HER2 Test System, Model 2000Ikonisys, Inc.20080—
+2K061602Duet SystemBioview, Ltd.20075—
+2K062755Ikoniscope Oncofish Bladder Test SystemIkonisys, Inc.20070—
+3K122554Genasis Scanview SystemApplied Spectral Imaging, Ltd.20130—
+3K101291Scanview HER2/Neu Fish SystemApplied Spectral Imaging, Ltd.20102—