510(k) Report

Devices descending from K980246

120 later devices reach Non-Mydriatic Retinal Camera, Model CR6-45NM through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K043213Kowa VX-10Kowa Co., Ltd.200531—
+1K043222Viscucam C Digital CameraCarl Zeiss Meditec, AG200522—
+1K041367Topcon Model TRC-NW200 Non-Mydriatic Retinal CameraTopcon Corp.200479—
+1K031629Canon Non-Mydriatic Retinal Camera, Model CR-DgiCanon USA, Inc.200392—
+1K014274Non-Mydriatic Fundus Camera, Model NM-1000Nidek, Inc.200296—
+2K123460TRC-NW300 Non-Mydriatic Retinal CameraTopcon Medical Systems, Inc.201311—
+2K113451Non-Mydriatic Auto Fundus Camera Afc-330 with Image Filing Software NA Vis-EXNidek Technologies Srl201212
+2K100207Non-Mydriatic Retinal Camera, Model TRC-NW8FTopcon Corp.201028—
+2K092374Ois Eyescan Portable Modular Imaging System, Model Ois EyescanOphthalmic Imaging Systems200922—
+2K090115Retina Camera TRC-NW7SF Mark IITopcon Corp.200930—
+2K080883CR-1Canon, Inc.200817—
+2K070231ORIONNidek Technologies Srl200722—
+2K062295Iri Integrated Retinal ImagerMedivision Medical Imaging, Ltd.200663—
+2K053026Kowa Nonmyd 7, Kowa Nonmyd a-DKowa Co., Ltd.20054—
+2K052268Visucam Pro NMCarl Zeiss Meditec, AG200521—
+2K023719MP-1 Micro PerimeterNidek Technologies Srl200230—
+3K202097Fundus CameraHuvitz Co., Ltd.20210—
+3K181444ClarusCarl Zeiss Meditec, Inc.20192—
+3K1615093D OCT-1 MaestroTopcon Corporation20168—
+3K152729Microperimeter MP-3Nidek Co., Ltd.20161—
+3K141325TRC-NW8F Plus Non-Mydriatic Retinal CameraTopcon Corp.20140—
+3K141481TRC-NW400 Non-Mydriatic Retinal CameraTopcon Corporation20141—
+3K123101TRC-50DX Retinal CameraTopcon Medical Systems, Inc.20132—
+3K130289TRC-NW8 Non-Mydriatic Retinal CameraTopcon Corp.20130—
+3K121043Optos Oct/Slo MicroperimeterOptos Plc.20130—
+3K121993Spectralis Hra + Oct and Variants, Spectralis FA+ Oct, Spectralis Icga +Oct, Spectralis…Heidelberg Engineering GmbH201215—
+3K112184Cirrus PhotoCarl Zeiss Meditec, Inc.201213—
+3K101628Kowa Nonmyd WXKowa Co., Ltd.20112—
+3K101935Centervue Digital Retinography SystemCentervue S.P.A.201021—
+3K101223Spectralis Hra+Oct, Spectralis FA_Oct, Spectralis Icga+ Oct, Spectralis Hra, Spectralis FAHeidelberg Engineering201041—
+3K092187Maia, Model 1Centervue S.P.A.20104—
+3K092565Digital Retinal Camera CX-1Canon Components, Inc.201014—
+3K091064Navilas Laser SystemOd-Os GmbH20093—
+3K090466Digital Retinal Camera, CR-1 Mark IICanon, Inc.20095—
+3K061768MP-1 MicroperimeterNidek Technologies Srl200627—
+3K062356Kowa Nonmyd Alpha-DKowa Co., Ltd.20060—
+4K221111Non-Mydriatic Retinal Camera NW500Topcon Corporation20220—
+4K202221VX650Luneau Technology Operations20210—
+4K190954Fundus CameraChongqing Bio Newvision Medical Equipment, Ltd.20200—
+4K191945KOWA nonmyd 8Kowa Company, Ltd.20190—
+4K191194ClarusCarl Zeiss Meditec, Inc.20191—
+4K190198Microperimeter MP-3, Microperimeter MP-3 Type SNidek Co., Ltd.20190—
+4K180229RESCAN 700, CALLISTO eyeCarl Zeiss Meditec, AG20191—
+4K180306NexyNext Sight Srl20182—
+4K173119DRI OCT TritonTopcon Corporation20180—
+4K171370IMAGEnet 6 Ophthalmic Data SystemTopcon Corporation201731
+4K1701643D OCT-1 MaestroTopcon Corporation20175—
+4K153181MAIACentervue S.P.A.20160—
+4K152205Spectralis HRA + OCT and variants (e.g.s below), Spectralis FA+OCT, Spectralis ICGA+OCT…Heidelberg Engineering GmbH201614—
+4K150467Retina WorkplaceCarl Zeiss Meditec, AG20153—
+4K141851Navilas Laser SystemOd-Os GmbH20152—
+4K141844Rescan 700, Callisto EyeCarl Zeiss Meditec, AG20145—
+4K142047EIDONCentervue S.P.A.20148—
+4K141297Forum Glaucoma WorkplaceCarl Zeiss Meditec, AG20141—
+4K132987Cobra Fundus CameraC.S.O. S.R.L.20140—
+4K133758Centervue Macular Integrity AssessmentCentervue S.P.A.20143—
+4K133217Cirrus PhotoCarl Zeiss Meditec, AG20143—
+4K122572Icam Fundus CameraOptovue, Inc.20138—
+4K112330Kowa VX-20Kowa Co., Ltd.20126—
+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—
+4K111612Digital Retinal CameraCanon, Inc.20113—
+4K102013Digital Retinal CameraCanon Inc. -Medical Equipment Group20104—
+5K250683Resolve Fundus CameraOptain Health, Inc.20250—
+5K243878Clarus (700)Carl Zeiss Meditec, Inc.20250—
+5K233421Rescan 700Carl Zeiss Meditec, AG20240—
+5K232828IMAGEnet6 Ophthalmic Data SystemTopcon Corporation202421
+5K2312223D OPTICAL COHERENCE TOMOGRAPHY 3D OCT-1(type: Maestro2)Topcon Corporation20233—
+5K222166SOLIXOptovue, Inc.20221—
+5K200954Glaucoma ModuleTopcon Healthcare Solutions, Inc.20200—
+5K200254Mydriatic Hyperspectral Retinal Camera (MHRC-C1)Optina Diagnostics20202—
+5K192113DRSplusCentervue S.P.A.20191—
+5K182199NFC-700 non-mydriatic auto fundus cameraCrystalvue Medical Corporation20193—
+5K182318Retina WorkplaceCarl Zeiss Meditec, Inc.20180—
+5K180526Eidon FACentervue S.P.A.20182—
+5K180858CALLISTO eyeCarl Zeiss Meditec, AG20182—
+5K180293Retia 2Centervue S.P.A.20180—
+5K172649Spectralis HRA + OCT and variants, Spectralis FA+OCT, Spectralis ICGA+OCT, Spectralis…Heidelberg Engineering GmbH201713—
+5K163195PrimusCarl Zeiss Suzhou Co., Ltd.20170—
+5K170638Retina WorkplaceCarl Zeiss Meditec, AG20172—
+5K162191NAVILAS Laser SystemOd-Os GmbH20161—
+5K150977Cirrus HD-OctCarl Zeiss Meditec, Inc.201511—
+5K150320CompassCentervue S.P.A.20151—
+5K130656IfusionOptovue, Inc.201301
+5K123208Digital Retinal CameraCanon Inc. -Medical Equipment Group20132—
+6K251848Pentacam® Cornea OCTOculus Optikgeräte GmbH20260—
+6K251772Navilas Laser System 577sl (156691)Od-Os GmbH20250—
+6K243504Maia (AHMACME001)Centervue S.P.A.20250—
+6K242508Verily Numetric Retinal CameraVerily Life Sciences, LLC20240—
+6K2410813D OPTICAL COHERENCE TOMOGRAPHY 3D OCT-1 (type: Maestro2); IMAGEnet6 Ophthalmic Data…Topcon Corporation20241—
+6K2335613D Optical Coherence Tomography (3D OCT-1(type: Maestro2))Topcon Corporation20242—
+6K231230Optina-4C (MHRC-C1N)Optina Diagnostics, Inc.20231—
+6K230627Zilia Ocular FC (ZIL-10002)Zilia, Inc.20230—
+6K231676CALLISTO eyeCarl Zeiss Meditec, AG20231—
+6K213705DRSplusCentervue S.P.A.20210—
+6K211328Eidon FA, Eidon, Eidon AF, Eidon UwflCentervue S.P.A.20211—
+6K210197NFC-600 Automated Portable Retinal CameraCrystalvue Medical Corporation20210—
+6K201273ImageSPECTRUMCanon, Inc.20200—
+6K201122Canon non-mydriatic retinal camera CR seriesCanon, Inc.20200—
+6K181534Cirrus HD-OctCarl Zeiss Meditec, Inc.201962