510(k) Report

Devices descending from K012103

14 later devices reach Bandview System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K050236FishviewApplied Spectral Imaging, Ltd.20054—
+1K040591Duet SystemBioview, Ltd.200412—
+1K030192Duet SystemBioview, Ltd.200313—
+2K130775Duet SystemBioview, Ltd.20140—
+2K071398Scanview, Model SC-300Applied Spectral Imaging, Ltd.20073—
+2K061602Duet SystemBioview, Ltd.20075—
+2K061392Ikoniscope Fastfish Auto/Amniocyte Test SystemIkonisys, Inc.20061—
+2K052577Ikoniscope Fastfish Amnio Imaging SystemIkonisys, Inc.20062—
+2K050840Modification to Duet SystemBioview, Ltd.20057—
+3K110345Scanview SystemApplied Spectral Imaging20111—
+3K101291Scanview HER2/Neu Fish SystemApplied Spectral Imaging, Ltd.20102—
+3K080909Iconoscope Oncofish HER2 Test System, Model 2000Ikonisys, Inc.20080—
+3K062755Ikoniscope Oncofish Bladder Test SystemIkonisys, Inc.20070—
+4K122554Genasis Scanview SystemApplied Spectral Imaging, Ltd.20130—