510(k) Report

Devices descending from K161509

8 later devices reach 3D OCT-1 Maestro through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K173119DRI OCT TritonTopcon Corporation20180—
+1K171370IMAGEnet 6 Ophthalmic Data SystemTopcon Corporation201731
+1K1701643D OCT-1 MaestroTopcon Corporation20175—
+2K232828IMAGEnet6 Ophthalmic Data SystemTopcon Corporation202421
+2K2312223D OPTICAL COHERENCE TOMOGRAPHY 3D OCT-1(type: Maestro2)Topcon Corporation20233—
+3K2410813D OPTICAL COHERENCE TOMOGRAPHY 3D OCT-1 (type: Maestro2); IMAGEnet6 Ophthalmic Data…Topcon Corporation20241—
+3K2335613D Optical Coherence Tomography (3D OCT-1(type: Maestro2))Topcon Corporation20242—
+4K253893Harmony Referral System with Harmony OCT Viewer (Octave)Topcon Healthcare Solutions EMEA Oy20260—