510(k) Report

Devices descending from K123460

11 later devices reach TRC-NW300 Non-Mydriatic Retinal Camera through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K1615093D OCT-1 MaestroTopcon Corporation20168—
+1K141481TRC-NW400 Non-Mydriatic Retinal CameraTopcon Corporation20141—
+2K221111Non-Mydriatic Retinal Camera NW500Topcon Corporation20220—
+2K173119DRI OCT TritonTopcon Corporation20180—
+2K171370IMAGEnet 6 Ophthalmic Data SystemTopcon Corporation201731
+2K1701643D OCT-1 MaestroTopcon Corporation20175—
+3K232828IMAGEnet6 Ophthalmic Data SystemTopcon Corporation202421
+3K2312223D OPTICAL COHERENCE TOMOGRAPHY 3D OCT-1(type: Maestro2)Topcon Corporation20233—
+4K2410813D OPTICAL COHERENCE TOMOGRAPHY 3D OCT-1 (type: Maestro2); IMAGEnet6 Ophthalmic Data…Topcon Corporation20241—
+4K2335613D Optical Coherence Tomography (3D OCT-1(type: Maestro2))Topcon Corporation20242—
+5K253893Harmony Referral System with Harmony OCT Viewer (Octave)Topcon Healthcare Solutions EMEA Oy20260—