510(k) Report

Devices descending from K063378

35 later devices reach Cirrus HD-Oct, Model 4000 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K092187Maia, Model 1Centervue S.P.A.20104—
+1K083291Cirrus HD-Oct with Retinal Nerve Fiber Layer and Macular Normative Databases, Model 4000Carl Zeiss Meditec, Inc.2009292
+2K133758Centervue Macular Integrity AssessmentCentervue S.P.A.20143—
+2K121622Nidek RS-3000Nidek Co., Ltd.20131—
+2K112184Cirrus PhotoCarl Zeiss Meditec, Inc.201213—
+2K111157CIRRUS HD-OCT WITH RETINAL NERVE FIBER LAYER, MACULAR, OPTIC NERVE HEAD, and GANGLION…Carl Zeiss Meditec, Inc.201224—
+2K093213Guided Progression Analysis on the Humphrey Field Analyzer II and II -I SeriesCarl Zeiss Meditec, Inc.20103—
+3K180229RESCAN 700, CALLISTO eyeCarl Zeiss Meditec, AG20191—
+3K163195PrimusCarl Zeiss Suzhou Co., Ltd.20170—
+3K153181MAIACentervue S.P.A.20160—
+3K150977Cirrus HD-OctCarl Zeiss Meditec, Inc.201511—
+3K150320CompassCentervue S.P.A.20151—
+3K150467Retina WorkplaceCarl Zeiss Meditec, AG20153—
+3K141844Rescan 700, Callisto EyeCarl Zeiss Meditec, AG20145—
+3K141297Forum Glaucoma WorkplaceCarl Zeiss Meditec, AG20141—
+3K133217Cirrus PhotoCarl Zeiss Meditec, AG20143—
+3K132323RS-3000 AdvanceNidek Co., Ltd.20140—
+3K130648Forum Glaucoma WorkplaceCarl Zeiss Meditec, AG20132—
+4K243504Maia (AHMACME001)Centervue S.P.A.20250—
+4K233421Rescan 700Carl Zeiss Meditec, AG20240—
+4K200954Glaucoma ModuleTopcon Healthcare Solutions, Inc.20200—
+4K181534Cirrus HD-OctCarl Zeiss Meditec, Inc.201962
+4K182318Retina WorkplaceCarl Zeiss Meditec, Inc.20180—
+4K180858CALLISTO eyeCarl Zeiss Meditec, AG20182—
+4K170638Retina WorkplaceCarl Zeiss Meditec, AG20172—
+4K161194PLEX Elite 9000 SS-OCTCarl Zeiss Meditec, Inc.201671
+5K2410813D OPTICAL COHERENCE TOMOGRAPHY 3D OCT-1 (type: Maestro2); IMAGEnet6 Ophthalmic Data…Topcon Corporation20241—
+5K231760HP-Oct (HP-Oct)Cylite Pty., Ltd.20241—
+5K231676CALLISTO eyeCarl Zeiss Meditec, AG20231—
+5K222200Cirrus HD-OctCarl Zeiss Meditec, Inc.20231—
+5K181501AfinaNeurovision Imaging, LLC20180—
+6K253893Harmony Referral System with Harmony OCT Viewer (Octave)Topcon Healthcare Solutions EMEA Oy20260—
+6K252633Unity DX (Udx)Cylite Pty., Ltd.20250—
+6K233933CIRRUS™ HD-OCT Model 6000Carl Zeiss Meditec, Inc.20240—
+6K232944CALLISTO eyeCarl Zeiss Meditec, AG20230—