510(k) Report

Devices descending from K151952

8 later devices reach Synergy ODM through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K182376HarmonyTopcon Medical Systems, Inc.20184—
+1K162039OptosAdvance 4.0 SoftwareOptos Plc.20172—
+2K232555HarmonyTopcon Healthcare Solutions20231—
+2K211715RetinAI DiscoveryRetinai Medical AG20221—
+2K210396Harmony Referral SystemTopcon Healthcare Solutions EMEA Oy20211—
+3K260694Zeiss Clinic 360Carl Zeiss Meditec, AG20260—
+3K253893Harmony Referral System with Harmony OCT Viewer (Octave)Topcon Healthcare Solutions EMEA Oy20260—
+3K232088Altris IMSAltris, Inc.20230—