510(k) Report

Devices descending from K091404

16 later devices reach Ivue, Model 100 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K121739Ivue with Normative DatabaseOptovue, Inc.2013143
+1K103266IstandOptovue, Inc.20110—
+2K233602P200TE (A10700)Optos Plc.20240—
+2K231673P200TE (A10700)Optos Plc.20231—
+2K163475iVueOptovue, Inc.20170—
+2K1615093D OCT-1 MaestroTopcon Corporation20168—
+2K133892IVUE 500Optovue, Inc.201402
+2K130656IfusionOptovue, Inc.201301
+3K173119DRI OCT TritonTopcon Corporation20180—
+3K171370IMAGEnet 6 Ophthalmic Data SystemTopcon Corporation201731
+3K1701643D OCT-1 MaestroTopcon Corporation20175—
+4K232828IMAGEnet6 Ophthalmic Data SystemTopcon Corporation202421
+4K2312223D OPTICAL COHERENCE TOMOGRAPHY 3D OCT-1(type: Maestro2)Topcon Corporation20233—
+5K2410813D OPTICAL COHERENCE TOMOGRAPHY 3D OCT-1 (type: Maestro2); IMAGEnet6 Ophthalmic Data…Topcon Corporation20241—
+5K2335613D Optical Coherence Tomography (3D OCT-1(type: Maestro2))Topcon Corporation20242—
+6K253893Harmony Referral System with Harmony OCT Viewer (Octave)Topcon Healthcare Solutions EMEA Oy20260—