510(k) Report

Devices descending from K182199

3 later devices reach NFC-700 non-mydriatic auto fundus camera through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K242508Verily Numetric Retinal CameraVerily Life Sciences, LLC20240—
+1K230627Zilia Ocular FC (ZIL-10002)Zilia, Inc.20230—
+1K210197NFC-600 Automated Portable Retinal CameraCrystalvue Medical Corporation20210—