510(k) Report

Devices descending from K902311

15 later devices reach Genevision - Computer Assisted Chromosome Karyo. through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K012103Bandview SystemApplied Spectral Imaging, Ltd.200114—
+2K050236FishviewApplied Spectral Imaging, Ltd.20054—
+2K040591Duet SystemBioview, Ltd.200412—
+2K030192Duet SystemBioview, Ltd.200313—
+3K130775Duet SystemBioview, Ltd.20140—
+3K071398Scanview, Model SC-300Applied Spectral Imaging, Ltd.20073—
+3K061602Duet SystemBioview, Ltd.20075—
+3K061392Ikoniscope Fastfish Auto/Amniocyte Test SystemIkonisys, Inc.20061—
+3K052577Ikoniscope Fastfish Amnio Imaging SystemIkonisys, Inc.20062—
+3K050840Modification to Duet SystemBioview, Ltd.20057—
+4K110345Scanview SystemApplied Spectral Imaging20111—
+4K101291Scanview HER2/Neu Fish SystemApplied Spectral Imaging, Ltd.20102—
+4K080909Iconoscope Oncofish HER2 Test System, Model 2000Ikonisys, Inc.20080—
+4K062755Ikoniscope Oncofish Bladder Test SystemIkonisys, Inc.20070—
+5K122554Genasis Scanview SystemApplied Spectral Imaging, Ltd.20130—