510(k) Report

Devices descending from K062295

63 later devices reach Iri Integrated Retinal Imager through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K121993Spectralis Hra + Oct and Variants, Spectralis FA+ Oct, Spectralis Icga +Oct, Spectralis…Heidelberg Engineering GmbH201215—
+1K101223Spectralis Hra+Oct, Spectralis FA_Oct, Spectralis Icga+ Oct, Spectralis Hra, Spectralis FAHeidelberg Engineering201041—
+1K092374Ois Eyescan Portable Modular Imaging System, Model Ois EyescanOphthalmic Imaging Systems200922—
+2K152205Spectralis HRA + OCT and variants (e.g.s below), Spectralis FA+OCT, Spectralis ICGA+OCT…Heidelberg Engineering GmbH201614—
+2K111157CIRRUS HD-OCT WITH RETINAL NERVE FIBER LAYER, MACULAR, OPTIC NERVE HEAD, and GANGLION…Carl Zeiss Meditec, Inc.201224—
+2K113129Spectralis Anterior Segment Module (Spectralis Asm)Heidelberg Engineering GmbH20110—
+2K101935Centervue Digital Retinography SystemCentervue S.P.A.201021—
+3K202221VX650Luneau Technology Operations20210—
+3K190954Fundus CameraChongqing Bio Newvision Medical Equipment, Ltd.20200—
+3K180306NexyNext Sight Srl20182—
+3K172649Spectralis HRA + OCT and variants, Spectralis FA+OCT, Spectralis ICGA+OCT, Spectralis…Heidelberg Engineering GmbH201713—
+3K163195PrimusCarl Zeiss Suzhou Co., Ltd.20170—
+3K150977Cirrus HD-OctCarl Zeiss Meditec, Inc.201511—
+3K150467Retina WorkplaceCarl Zeiss Meditec, AG20153—
+3K142047EIDONCentervue S.P.A.20148—
+3K141297Forum Glaucoma WorkplaceCarl Zeiss Meditec, AG20141—
+3K133217Cirrus PhotoCarl Zeiss Meditec, AG20143—
+3K122572Icam Fundus CameraOptovue, Inc.20138—
+3K112184Cirrus PhotoCarl Zeiss Meditec, Inc.201213—
+4K250683Resolve Fundus CameraOptain Health, Inc.20250—
+4K222166SOLIXOptovue, Inc.20221—
+4K200954Glaucoma ModuleTopcon Healthcare Solutions, Inc.20200—
+4K192113DRSplusCentervue S.P.A.20191—
+4K181534Cirrus HD-OctCarl Zeiss Meditec, Inc.201962
+4K180229RESCAN 700, CALLISTO eyeCarl Zeiss Meditec, AG20191—
+4K182199NFC-700 non-mydriatic auto fundus cameraCrystalvue Medical Corporation20193—
+4K182318Retina WorkplaceCarl Zeiss Meditec, Inc.20180—
+4K181594Spectralis HRA+OCT and variants with OCT Angiography ModuleHeidelberg Engineering GmbH201882
+4K173648Spectralis HRA + OCT and variantsHeidelberg Engineering GmbH20180—
+4K180526Eidon FACentervue S.P.A.20182—
+4K180293Retia 2Centervue S.P.A.20180—
+4K170638Retina WorkplaceCarl Zeiss Meditec, AG20172—
+4K161194PLEX Elite 9000 SS-OCTCarl Zeiss Meditec, Inc.201671
+4K150320CompassCentervue S.P.A.20151—
+4K141844Rescan 700, Callisto EyeCarl Zeiss Meditec, AG20145—
+4K130656IfusionOptovue, Inc.201301
+5K251848Pentacam® Cornea OCTOculus Optikgeräte GmbH20260—
+5K243504Maia (AHMACME001)Centervue S.P.A.20250—
+5K242508Verily Numetric Retinal CameraVerily Life Sciences, LLC20240—
+5K2410813D OPTICAL COHERENCE TOMOGRAPHY 3D OCT-1 (type: Maestro2); IMAGEnet6 Ophthalmic Data…Topcon Corporation20241—
+5K233421Rescan 700Carl Zeiss Meditec, AG20240—
+5K231760HP-Oct (HP-Oct)Cylite Pty., Ltd.20241—
+5K230627Zilia Ocular FC (ZIL-10002)Zilia, Inc.20230—
+5K222200Cirrus HD-OctCarl Zeiss Meditec, Inc.20231—
+5K213705DRSplusCentervue S.P.A.20210—
+5K211328Eidon FA, Eidon, Eidon AF, Eidon UwflCentervue S.P.A.20211—
+5K210197NFC-600 Automated Portable Retinal CameraCrystalvue Medical Corporation20210—
+5K181501AfinaNeurovision Imaging, LLC20180—
+5K182569Spectralis HRA+OCT and variants with High Magnification ModuleHeidelberg Engineering GmbH20187—
+5K180858CALLISTO eyeCarl Zeiss Meditec, AG20182—
+6K253893Harmony Referral System with Harmony OCT Viewer (Octave)Topcon Healthcare Solutions EMEA Oy20260—
+6K252633Unity DX (Udx)Cylite Pty., Ltd.20250—
+6K241931OcuMet Beacon (OCUB100)Ocusciences, Inc.20250—
+6K233933CIRRUS™ HD-OCT Model 6000Carl Zeiss Meditec, Inc.20240—
+6K231676CALLISTO eyeCarl Zeiss Meditec, AG20231—
+6K192391Spectralis HRA+OCT and VariantsHeidelberg Engineering GmbH20196—
+7K232944CALLISTO eyeCarl Zeiss Meditec, AG20230—
+7K201252Spectralis HRA+OCT and variantsHeidelberg Engineering GmbH20205—
+8K223557SPECTRALIS HRA+OCT and variantsHeidelberg Engineering GmbH20234—
+9K241163SPECTRALIS with Flex ModuleHeidelberg Engineering GmbH20241—
+9K240221SPECTRALIS HRA+OCT and variantsHeidelberg Engineering GmbH20242—
+10K253837SPECTRALIS HRA+OCT and variants; SPECTRALIS with Flex ModuleHeidelberg Engineering GmbH20260—
+10K250868SPECTRALIS HRA+OCT and variantsHeidelberg Engineering GmbH20251—