510(k) Report

Devices descending from K111157

24 later devices reach CIRRUS HD-OCT WITH RETINAL NERVE FIBER LAYER, MACULAR, OPTIC NERVE HEAD, and… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K163195PrimusCarl Zeiss Suzhou Co., Ltd.20170—
+1K150977Cirrus HD-OctCarl Zeiss Meditec, Inc.201511—
+1K150467Retina WorkplaceCarl Zeiss Meditec, AG20153—
+1K141297Forum Glaucoma WorkplaceCarl Zeiss Meditec, AG20141—
+1K133217Cirrus PhotoCarl Zeiss Meditec, AG20143—
+1K112184Cirrus PhotoCarl Zeiss Meditec, Inc.201213—
+2K200954Glaucoma ModuleTopcon Healthcare Solutions, Inc.20200—
+2K181534Cirrus HD-OctCarl Zeiss Meditec, Inc.201962
+2K180229RESCAN 700, CALLISTO eyeCarl Zeiss Meditec, AG20191—
+2K182318Retina WorkplaceCarl Zeiss Meditec, Inc.20180—
+2K170638Retina WorkplaceCarl Zeiss Meditec, AG20172—
+2K161194PLEX Elite 9000 SS-OCTCarl Zeiss Meditec, Inc.201671
+2K141844Rescan 700, Callisto EyeCarl Zeiss Meditec, AG20145—
+3K2410813D OPTICAL COHERENCE TOMOGRAPHY 3D OCT-1 (type: Maestro2); IMAGEnet6 Ophthalmic Data…Topcon Corporation20241—
+3K233421Rescan 700Carl Zeiss Meditec, AG20240—
+3K231760HP-Oct (HP-Oct)Cylite Pty., Ltd.20241—
+3K222200Cirrus HD-OctCarl Zeiss Meditec, Inc.20231—
+3K181501AfinaNeurovision Imaging, LLC20180—
+3K180858CALLISTO eyeCarl Zeiss Meditec, AG20182—
+4K253893Harmony Referral System with Harmony OCT Viewer (Octave)Topcon Healthcare Solutions EMEA Oy20260—
+4K252633Unity DX (Udx)Cylite Pty., Ltd.20250—
+4K233933CIRRUS™ HD-OCT Model 6000Carl Zeiss Meditec, Inc.20240—
+4K231676CALLISTO eyeCarl Zeiss Meditec, AG20231—
+5K232944CALLISTO eyeCarl Zeiss Meditec, AG20230—