510(k) Report

Devices descending from K121739

14 later devices reach Ivue with Normative Database through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K233602P200TE (A10700)Optos Plc.20240—
+1K231673P200TE (A10700)Optos Plc.20231—
+1K163475iVueOptovue, Inc.20170—
+1K1615093D OCT-1 MaestroTopcon Corporation20168—
+1K133892IVUE 500Optovue, Inc.201402
+1K130656IfusionOptovue, Inc.201301
+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—