510(k) Report

Devices descending from K061768

27 later devices reach MP-1 Microperimeter through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K190198Microperimeter MP-3, Microperimeter MP-3 Type SNidek Co., Ltd.20190—
+1K153181MAIACentervue S.P.A.20160—
+1K092187Maia, Model 1Centervue S.P.A.20104—
+1K070231ORIONNidek Technologies Srl200722—
+2K133758Centervue Macular Integrity AssessmentCentervue S.P.A.20143—
+2K101935Centervue Digital Retinography SystemCentervue S.P.A.201021—
+3K202221VX650Luneau Technology Operations20210—
+3K190954Fundus CameraChongqing Bio Newvision Medical Equipment, Ltd.20200—
+3K180306NexyNext Sight Srl20182—
+3K150320CompassCentervue S.P.A.20151—
+3K142047EIDONCentervue S.P.A.20148—
+3K122572Icam Fundus CameraOptovue, Inc.20138—
+4K250683Resolve Fundus CameraOptain Health, Inc.20250—
+4K243504Maia (AHMACME001)Centervue S.P.A.20250—
+4K222166SOLIXOptovue, Inc.20221—
+4K192113DRSplusCentervue S.P.A.20191—
+4K182199NFC-700 non-mydriatic auto fundus cameraCrystalvue Medical Corporation20193—
+4K180526Eidon FACentervue S.P.A.20182—
+4K180293Retia 2Centervue S.P.A.20180—
+4K130656IfusionOptovue, Inc.201301
+5K251848Pentacam® Cornea OCTOculus Optikgeräte GmbH20260—
+5K242508Verily Numetric Retinal CameraVerily Life Sciences, LLC20240—
+5K230627Zilia Ocular FC (ZIL-10002)Zilia, Inc.20230—
+5K213705DRSplusCentervue S.P.A.20210—
+5K211328Eidon FA, Eidon, Eidon AF, Eidon UwflCentervue S.P.A.20211—
+5K210197NFC-600 Automated Portable Retinal CameraCrystalvue Medical Corporation20210—
+6K241931OcuMet Beacon (OCUB100)Ocusciences, Inc.20250—