510(k) Report

Devices descending from K132438

7 later devices reach Imagenet 5 PC Software System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K173689Ophthalmic Software Platform RXCanon Inc. -Medical Equipment Group20182—
+1K171370IMAGEnet 6 Ophthalmic Data SystemTopcon Corporation201731
+2K232828IMAGEnet6 Ophthalmic Data SystemTopcon Corporation202421
+2K201273ImageSPECTRUMCanon, Inc.20200—
+2K190056KOWA VK-2sKowa Co. Ltd. Chofu201901
+3K2410813D OPTICAL COHERENCE TOMOGRAPHY 3D OCT-1 (type: Maestro2); IMAGEnet6 Ophthalmic Data…Topcon Corporation20241—
+4K253893Harmony Referral System with Harmony OCT Viewer (Octave)Topcon Healthcare Solutions EMEA Oy20260—