510(k) Report

Devices descending from K913929

53 later devices reach DFC-1024 & DFC-512 Digital Imaging System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K092374Ois Eyescan Portable Modular Imaging System, Model Ois EyescanOphthalmic Imaging Systems200922—
+1K974535Discam Digital Imaging SystemMarcher Enterprises, Ltd.19983—
+1K980295Ophthavision Imaging SystemMrp Group, Inc.199823—
+1K971685Imagescape Digital Retinal Image SystemTomey Corporation USA199725—
+2K102412Vista Digital OpthalmoscopeEyequick.Llc20112—
+2K101861Truevision 3D Visualization and Guidance SystemTruevision Systems, Incorporated201013—
+2K101935Centervue Digital Retinography SystemCentervue S.P.A.201021—
+2K091935Lipiview Ocular Surface InterferometerTearscience, Inc.20096—
+2K022164Zeta Diagnostic Retinal Imaging SystemZeta Development Laboratories20021—
+2K990205Digiscope Ophthalmic CameraEye Tel Imaging, Inc.19990—
+3K202221VX650Luneau Technology Operations20210—
+3K190954Fundus CameraChongqing Bio Newvision Medical Equipment, Ltd.20200—
+3K190573KOWA DR-1aKowa Company, Ltd.20190—
+3K180306NexyNext Sight Srl20182—
+3K152869LipiView II Ocular Surface InterferometerTearscience, Inc.20161—
+3K142047EIDONCentervue S.P.A.20148—
+3K141068Zeiss Cataract Suite MarkerlessCarl Zeiss Meditec, AG20148—
+3K123464Callisto EyeCarl Zeiss Meditec, AG20136—
+3K122572Icam Fundus CameraOptovue, Inc.20138—
+3K122481Lipiview Ocular Surface InterferometerTearscience, Inc.20122—
+3K121405PanopticWelch Allyn, Inc.20121—
+3K111771Non-Contact Tear Film ThermograghUnited Integrated Services Co., Ltd.20111—
+3K093071Fundus Photo Ophthalmic Digital Imaging System, Model CFD-440Fundus Photo, LLC20100—
+4K253176TearViewBeyond 700 Pty, Ltd.20260—
+4K250683Resolve Fundus CameraOptain Health, Inc.20250—
+4K223381iExaminer System with Panoptic PlusWelch Allyn, Inc.20230—
+4K222166SOLIXOptovue, Inc.20221—
+4K192113DRSplusCentervue S.P.A.20191—
+4K182199NFC-700 non-mydriatic auto fundus cameraCrystalvue Medical Corporation20193—
+4K182506LipiScan Dynamic Meibomian ImagerTearscience, Inc.20180—
+4K180526Eidon FACentervue S.P.A.20182—
+4K180858CALLISTO eyeCarl Zeiss Meditec, AG20182—
+4K180293Retia 2Centervue S.P.A.20180—
+4K143275IOLMaster700Carl Zeiss Meditec, Inc.20154—
+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—
+5K230627Zilia Ocular FC (ZIL-10002)Zilia, Inc.20230—
+5K231676CALLISTO eyeCarl Zeiss Meditec, AG20231—
+5K213705DRSplusCentervue S.P.A.20210—
+5K211328Eidon FA, Eidon, Eidon AF, Eidon UwflCentervue S.P.A.20211—
+5K210197NFC-600 Automated Portable Retinal CameraCrystalvue Medical Corporation20210—
+5K191051ARGOSSantec Corporation20190—
+5K180229RESCAN 700, CALLISTO eyeCarl Zeiss Meditec, AG20191—
+5K170171IOLMaster 700Carl Zeiss Meditec, AG201731
+6K241931OcuMet Beacon (OCUB100)Ocusciences, Inc.20250—
+6K233421Rescan 700Carl Zeiss Meditec, AG20240—
+6K232944CALLISTO eyeCarl Zeiss Meditec, AG20230—
+6K173771IOLMaster 700Carl Zeiss Meditec, AG201811
+7K252633Unity DX (Udx)Cylite Pty., Ltd.20250—