510(k) Report

Devices descending from K171370

3 later devices reach IMAGEnet 6 Ophthalmic Data System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K232828IMAGEnet6 Ophthalmic Data SystemTopcon Corporation202421
+2K2410813D OPTICAL COHERENCE TOMOGRAPHY 3D OCT-1 (type: Maestro2); IMAGEnet6 Ophthalmic Data…Topcon Corporation20241—
+3K253893Harmony Referral System with Harmony OCT Viewer (Octave)Topcon Healthcare Solutions EMEA Oy20260—