510(k) Report

Devices descending from K011877

83 later devices reach FF450 Plus Fundus Camera and Visupac Digital Image Archiving System, or FF450… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K112184Cirrus PhotoCarl Zeiss Meditec, Inc.201213—
+1K113451Non-Mydriatic Auto Fundus Camera Afc-330 with Image Filing Software NA Vis-EXNidek Technologies Srl201212
+1K091064Navilas Laser SystemOd-Os GmbH20093—
+1K082196Static Vessel AnalyzerImedos GmbH20090—
+1K062416Retinal Functional Imager (Rfi)Optical Imaging, Ltd.20063—
+1K053044Opto Global Digital Fundus Camera System Model Ads 1.5Opto Global, Inc.20064—
+1K020888Fundus AutoimagerVisual Pathways, Inc.20020—
+1K021787VisucamCarl Zeiss Ophthalmic Systems, Inc.200274—
+2K202097Fundus CameraHuvitz Co., Ltd.20210—
+2K180229RESCAN 700, CALLISTO eyeCarl Zeiss Meditec, AG20191—
+2K153239LSFG-NaviSoftcare Co., Ltd.20160—
+2K150467Retina WorkplaceCarl Zeiss Meditec, AG20153—
+2K141851Navilas Laser SystemOd-Os GmbH20152—
+2K141844Rescan 700, Callisto EyeCarl Zeiss Meditec, AG20145—
+2K141297Forum Glaucoma WorkplaceCarl Zeiss Meditec, AG20141—
+2K133217Cirrus PhotoCarl Zeiss Meditec, AG20143—
+2K080180Modification to Retinal Function Imager (Rfi)Optical Imaging, Ltd.20081—
+2K062295Iri Integrated Retinal ImagerMedivision Medical Imaging, Ltd.200663—
+2K043222Viscucam C Digital CameraCarl Zeiss Meditec, AG200522—
+3K233421Rescan 700Carl Zeiss Meditec, AG20240—
+3K200954Glaucoma ModuleTopcon Healthcare Solutions, Inc.20200—
+3K193319XyCAM RI, XyCAM RI System, XyCAM Retinal Imaging SystemVasoptic Medical, Inc.20200—
+3K182318Retina WorkplaceCarl Zeiss Meditec, Inc.20180—
+3K180858CALLISTO eyeCarl Zeiss Meditec, AG20182—
+3K170638Retina WorkplaceCarl Zeiss Meditec, AG20172—
+3K162191NAVILAS Laser SystemOd-Os GmbH20161—
+3K121993Spectralis Hra + Oct and Variants, Spectralis FA+ Oct, Spectralis Icga +Oct, Spectralis…Heidelberg Engineering GmbH201215—
+3K101223Spectralis Hra+Oct, Spectralis FA_Oct, Spectralis Icga+ Oct, Spectralis Hra, Spectralis FAHeidelberg Engineering201041—
+3K092374Ois Eyescan Portable Modular Imaging System, Model Ois EyescanOphthalmic Imaging Systems200922—
+3K052268Visucam Pro NMCarl Zeiss Meditec, AG200521—
+4K251772Navilas Laser System 577sl (156691)Od-Os GmbH20250—
+4K231676CALLISTO eyeCarl Zeiss Meditec, AG20231—
+4K181444ClarusCarl Zeiss Meditec, Inc.20192—
+4K181501AfinaNeurovision Imaging, LLC20180—
+4K152205Spectralis HRA + OCT and variants (e.g.s below), Spectralis FA+OCT, Spectralis ICGA+OCT…Heidelberg Engineering GmbH201614—
+4K111157CIRRUS HD-OCT WITH RETINAL NERVE FIBER LAYER, MACULAR, OPTIC NERVE HEAD, and GANGLION…Carl Zeiss Meditec, Inc.201224—
+4K113129Spectralis Anterior Segment Module (Spectralis Asm)Heidelberg Engineering GmbH20110—
+4K101935Centervue Digital Retinography SystemCentervue S.P.A.201021—
+5K232944CALLISTO eyeCarl Zeiss Meditec, AG20230—
+5K202221VX650Luneau Technology Operations20210—
+5K190954Fundus CameraChongqing Bio Newvision Medical Equipment, Ltd.20200—
+5K191194ClarusCarl Zeiss Meditec, Inc.20191—
+5K180306NexyNext Sight Srl20182—
+5K172649Spectralis HRA + OCT and variants, Spectralis FA+OCT, Spectralis ICGA+OCT, Spectralis…Heidelberg Engineering GmbH201713—
+5K163195PrimusCarl Zeiss Suzhou Co., Ltd.20170—
+5K150977Cirrus HD-OctCarl Zeiss Meditec, Inc.201511—
+5K142047EIDONCentervue S.P.A.20148—
+5K122572Icam Fundus CameraOptovue, Inc.20138—
+6K250683Resolve Fundus CameraOptain Health, Inc.20250—
+6K243878Clarus (700)Carl Zeiss Meditec, Inc.20250—
+6K222166SOLIXOptovue, Inc.20221—
+6K192113DRSplusCentervue S.P.A.20191—
+6K181534Cirrus HD-OctCarl Zeiss Meditec, Inc.201962
+6K182199NFC-700 non-mydriatic auto fundus cameraCrystalvue Medical Corporation20193—
+6K181594Spectralis HRA+OCT and variants with OCT Angiography ModuleHeidelberg Engineering GmbH201882
+6K173648Spectralis HRA + OCT and variantsHeidelberg Engineering GmbH20180—
+6K180526Eidon FACentervue S.P.A.20182—
+6K180293Retia 2Centervue S.P.A.20180—
+6K161194PLEX Elite 9000 SS-OCTCarl Zeiss Meditec, Inc.201671
+6K150320CompassCentervue S.P.A.20151—
+6K130656IfusionOptovue, Inc.201301
+7K251848Pentacam® Cornea OCTOculus Optikgeräte GmbH20260—
+7K243504Maia (AHMACME001)Centervue S.P.A.20250—
+7K242508Verily Numetric Retinal CameraVerily Life Sciences, LLC20240—
+7K2410813D OPTICAL COHERENCE TOMOGRAPHY 3D OCT-1 (type: Maestro2); IMAGEnet6 Ophthalmic Data…Topcon Corporation20241—
+7K231760HP-Oct (HP-Oct)Cylite Pty., Ltd.20241—
+7K230627Zilia Ocular FC (ZIL-10002)Zilia, Inc.20230—
+7K222200Cirrus HD-OctCarl Zeiss Meditec, Inc.20231—
+7K213705DRSplusCentervue S.P.A.20210—
+7K211328Eidon FA, Eidon, Eidon AF, Eidon UwflCentervue S.P.A.20211—
+7K210197NFC-600 Automated Portable Retinal CameraCrystalvue Medical Corporation20210—
+7K182569Spectralis HRA+OCT and variants with High Magnification ModuleHeidelberg Engineering GmbH20187—
+8K253893Harmony Referral System with Harmony OCT Viewer (Octave)Topcon Healthcare Solutions EMEA Oy20260—
+8K252633Unity DX (Udx)Cylite Pty., Ltd.20250—
+8K241931OcuMet Beacon (OCUB100)Ocusciences, Inc.20250—
+8K233933CIRRUS™ HD-OCT Model 6000Carl Zeiss Meditec, Inc.20240—
+8K192391Spectralis HRA+OCT and VariantsHeidelberg Engineering GmbH20196—
+9K201252Spectralis HRA+OCT and variantsHeidelberg Engineering GmbH20205—
+10K223557SPECTRALIS HRA+OCT and variantsHeidelberg Engineering GmbH20234—
+11K241163SPECTRALIS with Flex ModuleHeidelberg Engineering GmbH20241—
+11K240221SPECTRALIS HRA+OCT and variantsHeidelberg Engineering GmbH20242—
+12K253837SPECTRALIS HRA+OCT and variants; SPECTRALIS with Flex ModuleHeidelberg Engineering GmbH20260—
+12K250868SPECTRALIS HRA+OCT and variantsHeidelberg Engineering GmbH20251—