510(k) Report

Devices descending from K083316

15 later devices reach 3D Oct-1000 Mark II Optical Coherence Tomography System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K092470Optical Coherence Tomography 3D Oct-2000Topcon Corp.200914—
+2K112184Cirrus PhotoCarl Zeiss Meditec, Inc.201213—
+3K180229RESCAN 700, CALLISTO eyeCarl Zeiss Meditec, AG20191—
+3K150467Retina WorkplaceCarl Zeiss Meditec, AG20153—
+3K141844Rescan 700, Callisto EyeCarl Zeiss Meditec, AG20145—
+3K141297Forum Glaucoma WorkplaceCarl Zeiss Meditec, AG20141—
+3K133217Cirrus PhotoCarl Zeiss Meditec, AG20143—
+4K233421Rescan 700Carl Zeiss Meditec, AG20240—
+4K200954Glaucoma ModuleTopcon Healthcare Solutions, Inc.20200—
+4K182318Retina WorkplaceCarl Zeiss Meditec, Inc.20180—
+4K180858CALLISTO eyeCarl Zeiss Meditec, AG20182—
+4K170638Retina WorkplaceCarl Zeiss Meditec, AG20172—
+5K231676CALLISTO eyeCarl Zeiss Meditec, AG20231—
+5K181501AfinaNeurovision Imaging, LLC20180—
+6K232944CALLISTO eyeCarl Zeiss Meditec, AG20230—