510(k) Report

Devices descending from K162039

2 later devices reach OptosAdvance 4.0 Software through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K211715RetinAI DiscoveryRetinai Medical AG20221—
+2K232088Altris IMSAltris, Inc.20230—