510(k) Report

Devices descending from K181534

6 later devices reach Cirrus HD-Oct through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K2410813D OPTICAL COHERENCE TOMOGRAPHY 3D OCT-1 (type: Maestro2); IMAGEnet6 Ophthalmic Data…Topcon Corporation20241—
+1K231760HP-Oct (HP-Oct)Cylite Pty., Ltd.20241—
+1K222200Cirrus HD-OctCarl Zeiss Meditec, Inc.20231—
+2K253893Harmony Referral System with Harmony OCT Viewer (Octave)Topcon Healthcare Solutions EMEA Oy20260—
+2K252633Unity DX (Udx)Cylite Pty., Ltd.20250—
+2K233933CIRRUS™ HD-OCT Model 6000Carl Zeiss Meditec, Inc.20240—