510(k) Report

Devices descending from K101223

41 later devices reach Spectralis Hra+Oct, Spectralis FA_Oct, Spectralis Icga+ Oct, Spectralis Hra… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K152205Spectralis HRA + OCT and variants (e.g.s below), Spectralis FA+OCT, Spectralis ICGA+OCT…Heidelberg Engineering GmbH201614—
+1K111157CIRRUS HD-OCT WITH RETINAL NERVE FIBER LAYER, MACULAR, OPTIC NERVE HEAD, and GANGLION…Carl Zeiss Meditec, Inc.201224—
+1K113129Spectralis Anterior Segment Module (Spectralis Asm)Heidelberg Engineering GmbH20110—
+2K172649Spectralis HRA + OCT and variants, Spectralis FA+OCT, Spectralis ICGA+OCT, Spectralis…Heidelberg Engineering GmbH201713—
+2K163195PrimusCarl Zeiss Suzhou Co., Ltd.20170—
+2K150977Cirrus HD-OctCarl Zeiss Meditec, Inc.201511—
+2K150467Retina WorkplaceCarl Zeiss Meditec, AG20153—
+2K141297Forum Glaucoma WorkplaceCarl Zeiss Meditec, AG20141—
+2K133217Cirrus PhotoCarl Zeiss Meditec, AG20143—
+2K112184Cirrus PhotoCarl Zeiss Meditec, Inc.201213—
+3K200954Glaucoma ModuleTopcon Healthcare Solutions, Inc.20200—
+3K181534Cirrus HD-OctCarl Zeiss Meditec, Inc.201962
+3K180229RESCAN 700, CALLISTO eyeCarl Zeiss Meditec, AG20191—
+3K182318Retina WorkplaceCarl Zeiss Meditec, Inc.20180—
+3K181594Spectralis HRA+OCT and variants with OCT Angiography ModuleHeidelberg Engineering GmbH201882
+3K173648Spectralis HRA + OCT and variantsHeidelberg Engineering GmbH20180—
+3K180526Eidon FACentervue S.P.A.20182—
+3K170638Retina WorkplaceCarl Zeiss Meditec, AG20172—
+3K161194PLEX Elite 9000 SS-OCTCarl Zeiss Meditec, Inc.201671
+3K141844Rescan 700, Callisto EyeCarl Zeiss Meditec, AG20145—
+4K2410813D OPTICAL COHERENCE TOMOGRAPHY 3D OCT-1 (type: Maestro2); IMAGEnet6 Ophthalmic Data…Topcon Corporation20241—
+4K233421Rescan 700Carl Zeiss Meditec, AG20240—
+4K231760HP-Oct (HP-Oct)Cylite Pty., Ltd.20241—
+4K222200Cirrus HD-OctCarl Zeiss Meditec, Inc.20231—
+4K211328Eidon FA, Eidon, Eidon AF, Eidon UwflCentervue S.P.A.20211—
+4K181501AfinaNeurovision Imaging, LLC20180—
+4K182569Spectralis HRA+OCT and variants with High Magnification ModuleHeidelberg Engineering GmbH20187—
+4K180858CALLISTO eyeCarl Zeiss Meditec, AG20182—
+5K253893Harmony Referral System with Harmony OCT Viewer (Octave)Topcon Healthcare Solutions EMEA Oy20260—
+5K252633Unity DX (Udx)Cylite Pty., Ltd.20250—
+5K241931OcuMet Beacon (OCUB100)Ocusciences, Inc.20250—
+5K233933CIRRUS™ HD-OCT Model 6000Carl Zeiss Meditec, Inc.20240—
+5K231676CALLISTO eyeCarl Zeiss Meditec, AG20231—
+5K192391Spectralis HRA+OCT and VariantsHeidelberg Engineering GmbH20196—
+6K232944CALLISTO eyeCarl Zeiss Meditec, AG20230—
+6K201252Spectralis HRA+OCT and variantsHeidelberg Engineering GmbH20205—
+7K223557SPECTRALIS HRA+OCT and variantsHeidelberg Engineering GmbH20234—
+8K241163SPECTRALIS with Flex ModuleHeidelberg Engineering GmbH20241—
+8K240221SPECTRALIS HRA+OCT and variantsHeidelberg Engineering GmbH20242—
+9K253837SPECTRALIS HRA+OCT and variants; SPECTRALIS with Flex ModuleHeidelberg Engineering GmbH20260—
+9K250868SPECTRALIS HRA+OCT and variantsHeidelberg Engineering GmbH20251—