510(k) Report

Devices descending from K040591

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K130775Duet SystemBioview, Ltd.20140—
+1K061602Duet SystemBioview, Ltd.20075—
+1K061392Ikoniscope Fastfish Auto/Amniocyte Test SystemIkonisys, Inc.20061—
+1K052577Ikoniscope Fastfish Amnio Imaging SystemIkonisys, Inc.20062—
+1K050840Modification to Duet SystemBioview, Ltd.20057—
+1K050236FishviewApplied Spectral Imaging, Ltd.20054—
+2K110345Scanview SystemApplied Spectral Imaging20111—
+2K101291Scanview HER2/Neu Fish SystemApplied Spectral Imaging, Ltd.20102—
+2K080909Iconoscope Oncofish HER2 Test System, Model 2000Ikonisys, Inc.20080—
+2K071398Scanview, Model SC-300Applied Spectral Imaging, Ltd.20073—
+2K062755Ikoniscope Oncofish Bladder Test SystemIkonisys, Inc.20070—
+3K122554Genasis Scanview SystemApplied Spectral Imaging, Ltd.20130—