510(k) Report

Devices descending from K132667

9 later devices reach Synergy Odm through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K151952Synergy ODMTopcon Medical Systems, Inc.20158—
+2K182376HarmonyTopcon Medical Systems, Inc.20184—
+2K162039OptosAdvance 4.0 SoftwareOptos Plc.20172—
+3K232555HarmonyTopcon Healthcare Solutions20231—
+3K211715RetinAI DiscoveryRetinai Medical AG20221—
+3K210396Harmony Referral SystemTopcon Healthcare Solutions EMEA Oy20211—
+4K260694Zeiss Clinic 360Carl Zeiss Meditec, AG20260—
+4K253893Harmony Referral System with Harmony OCT Viewer (Octave)Topcon Healthcare Solutions EMEA Oy20260—
+4K232088Altris IMSAltris, Inc.20230—