510(k) Report

Devices descending from K070231

22 later devices reach ORION through their predicates, nearest generation first.

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