510(k) Report

Devices descending from K101505

58 later devices reach Rtvue Model Rtvue 100 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K121622Nidek RS-3000Nidek Co., Ltd.20131—
+1K121739Ivue with Normative DatabaseOptovue, Inc.2013143
+1K120238Rtvue XR OctOptovue, Inc.201217—
+1K111157CIRRUS HD-OCT WITH RETINAL NERVE FIBER LAYER, MACULAR, OPTIC NERVE HEAD, and GANGLION…Carl Zeiss Meditec, Inc.201224—
+2K233602P200TE (A10700)Optos Plc.20240—
+2K231673P200TE (A10700)Optos Plc.20231—
+2K163195PrimusCarl Zeiss Suzhou Co., Ltd.20170—
+2K163475iVueOptovue, Inc.20170—
+2K1615093D OCT-1 MaestroTopcon Corporation20168—
+2K153080RTVue XR OCT Avanti with AngioVue SoftwareOptovue, Inc.201616—
+2K150977Cirrus HD-OctCarl Zeiss Meditec, Inc.201511—
+2K150467Retina WorkplaceCarl Zeiss Meditec, AG20153—
+2K141297Forum Glaucoma WorkplaceCarl Zeiss Meditec, AG20141—
+2K133217Cirrus PhotoCarl Zeiss Meditec, AG20143—
+2K133892IVUE 500Optovue, Inc.201402
+2K132323RS-3000 AdvanceNidek Co., Ltd.20140—
+2K130656IfusionOptovue, Inc.201301
+2K112184Cirrus PhotoCarl Zeiss Meditec, Inc.201213—
+3K200954Glaucoma ModuleTopcon Healthcare Solutions, Inc.20200—
+3K182942Canon OCT-A1Canon, Inc.20190—
+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
+3K180660AvantiOptovue, Inc.20185—
+3K173119DRI OCT TritonTopcon Corporation20180—
+3K171370IMAGEnet 6 Ophthalmic Data SystemTopcon Corporation201731
+3K170638Retina WorkplaceCarl Zeiss Meditec, AG20172—
+3K1701643D OCT-1 MaestroTopcon Corporation20175—
+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—
+4K232828IMAGEnet6 Ophthalmic Data SystemTopcon Corporation202421
+4K2312223D OPTICAL COHERENCE TOMOGRAPHY 3D OCT-1(type: Maestro2)Topcon Corporation20233—
+4K222200Cirrus HD-OctCarl Zeiss Meditec, Inc.20231—
+4K221320Scanning Laser Ophthalmoscope Mirante [SLO/OCT Model] with Image Filing Software…Nidek Co., Ltd.20230—
+4K222166SOLIXOptovue, Inc.20221—
+4K213265Tomey Cornea/Anterior Segment OCT CASIA2Tomey Corporation20221—
+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—
+5K251848Pentacam® Cornea OCTOculus Optikgeräte GmbH20260—
+5K252633Unity DX (Udx)Cylite Pty., Ltd.20250—
+5K250553Tomey Cornea/Anterior Segment OCT (CASIA2)Tomey Corporation20250—
+5K233933CIRRUS™ HD-OCT Model 6000Carl Zeiss Meditec, Inc.20240—
+5K2335613D Optical Coherence Tomography (3D OCT-1(type: Maestro2))Topcon Corporation20242—
+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—