510(k) Report

Devices descending from K113696

4 later devices reach Optos Advance through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K162039OptosAdvance 4.0 SoftwareOptos Plc.20172—
+1K141922Iris Intelligent Retinal Imaging SystemIntelligent Retinal Imaging Systems, LLC20150—
+2K211715RetinAI DiscoveryRetinai Medical AG20221—
+3K232088Altris IMSAltris, Inc.20230—