510(k) Report

Devices descending from K925670

31 later devices reach IMS-200 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K003301Diffmaster Octavia Automatic Hematology AnalyzerCellaVision AB200112—
+1K984188Automated Cellular Imaging System (Acis)Chroma Vision Medical Systems, Inc.199914—
+1K980375Winscan Automated Imaging SystemApplied Imaging Corp.19980—
+1K960774MICRO21 with AnaTriangle Biomedical Sciences, Inc.19960—
+1K960776MICRO21 with ReticTriangle Biomedical Sciences, Inc.19960—
+2K033840Cellavision DM96 Automatic Hematology AnalyzerCellaVision AB2004111
+2K030192Duet SystemBioview, Ltd.200313—
+3K171315Advanced RBC ApplicationCellaVision AB20170—
+3K130775Duet SystemBioview, Ltd.20140—
+3K092116Easycell Cell LocatorMedica Corp.20103—
+3K092868Cellavision DM1200 Automated Hematology Analyzer, Model XU-10127CellaVision AB200942
+3K080595Cellavision DM96 with the Body Fluid ApplicationCellaVision AB20081—
+3K061602Duet SystemBioview, Ltd.20075—
+3K050840Modification to Duet SystemBioview, Ltd.20057—
+3K040591Duet SystemBioview, Ltd.200412—
+4K200595CellaVision DC-1, CellaVision DC-1 PPACellaVision AB20201—
+4K201301X100 with Full Field Peripheral Blood Smear (PBS) ApplicationScopio Labs, Ltd.20202—
+4K171655cobas m 511 integrated hematology analyzerRoche Diagnostics Hematology, Inc.201801
+4K110345Scanview SystemApplied Spectral Imaging20111—
+4K102778Cellavision DM1200 with the Body Fluid ApplictionCellaVision AB20110—
+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—
+4K061392Ikoniscope Fastfish Auto/Amniocyte Test SystemIkonisys, Inc.20061—
+4K052577Ikoniscope Fastfish Amnio Imaging SystemIkonisys, Inc.20062—
+4K050236FishviewApplied Spectral Imaging, Ltd.20054—
+5K243144X100/X100HT with Full Field Peripheral Blood Smear (PBS) ApplicationScopio Labs, Ltd.20250—
+5K221309AI100 with ShonitSigtuple Technologies Pvt., Ltd.20230—
+5K220013X100HT with Slide Loader with Full Field Peripheral Blood Smear (PBS) ApplicationScopio Labs, Ltd.20221—
+5K122554Genasis Scanview SystemApplied Spectral Imaging, Ltd.20130—
+5K071398Scanview, Model SC-300Applied Spectral Imaging, Ltd.20073—