510(k) Report

Devices descending from K161194

7 later devices reach PLEX Elite 9000 SS-OCT through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K181534Cirrus HD-OctCarl Zeiss Meditec, Inc.201962
+2K2410813D OPTICAL COHERENCE TOMOGRAPHY 3D OCT-1 (type: Maestro2); IMAGEnet6 Ophthalmic Data…Topcon Corporation20241—
+2K231760HP-Oct (HP-Oct)Cylite Pty., Ltd.20241—
+2K222200Cirrus HD-OctCarl Zeiss Meditec, Inc.20231—
+3K253893Harmony Referral System with Harmony OCT Viewer (Octave)Topcon Healthcare Solutions EMEA Oy20260—
+3K252633Unity DX (Udx)Cylite Pty., Ltd.20250—
+3K233933CIRRUS™ HD-OCT Model 6000Carl Zeiss Meditec, Inc.20240—