510(k) Report

Devices descending from K810880

28 later devices reach AR-1 Physiological Prodessor through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K061768MP-1 MicroperimeterNidek Technologies Srl200627—
+2K190198Microperimeter MP-3, Microperimeter MP-3 Type SNidek Co., Ltd.20190—
+2K153181MAIACentervue S.P.A.20160—
+2K092187Maia, Model 1Centervue S.P.A.20104—
+2K070231ORIONNidek Technologies Srl200722—
+3K133758Centervue Macular Integrity AssessmentCentervue S.P.A.20143—
+3K101935Centervue Digital Retinography SystemCentervue S.P.A.201021—
+4K202221VX650Luneau Technology Operations20210—
+4K190954Fundus CameraChongqing Bio Newvision Medical Equipment, Ltd.20200—
+4K180306NexyNext Sight Srl20182—
+4K150320CompassCentervue S.P.A.20151—
+4K142047EIDONCentervue S.P.A.20148—
+4K122572Icam Fundus CameraOptovue, Inc.20138—
+5K250683Resolve Fundus CameraOptain Health, Inc.20250—
+5K243504Maia (AHMACME001)Centervue S.P.A.20250—
+5K222166SOLIXOptovue, Inc.20221—
+5K192113DRSplusCentervue S.P.A.20191—
+5K182199NFC-700 non-mydriatic auto fundus cameraCrystalvue Medical Corporation20193—
+5K180526Eidon FACentervue S.P.A.20182—
+5K180293Retia 2Centervue S.P.A.20180—
+5K130656IfusionOptovue, Inc.201301
+6K251848Pentacam® Cornea OCTOculus Optikgeräte GmbH20260—
+6K242508Verily Numetric Retinal CameraVerily Life Sciences, LLC20240—
+6K230627Zilia Ocular FC (ZIL-10002)Zilia, Inc.20230—
+6K213705DRSplusCentervue S.P.A.20210—
+6K211328Eidon FA, Eidon, Eidon AF, Eidon UwflCentervue S.P.A.20211—
+6K210197NFC-600 Automated Portable Retinal CameraCrystalvue Medical Corporation20210—
+7K241931OcuMet Beacon (OCUB100)Ocusciences, Inc.20250—