510(k) Report

Devices descending from K182376

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K232555HarmonyTopcon Healthcare Solutions20231—
+1K210396Harmony Referral SystemTopcon Healthcare Solutions EMEA Oy20211—
+2K260694Zeiss Clinic 360Carl Zeiss Meditec, AG20260—
+2K253893Harmony Referral System with Harmony OCT Viewer (Octave)Topcon Healthcare Solutions EMEA Oy20260—