510(k) Report

Devices descending from K033123

77 later devices reach Stratusoct with RNFL & Macula Normative Database through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K101505Rtvue Model Rtvue 100Optovue, Inc.2010581
+1K083291Cirrus HD-Oct with Retinal Nerve Fiber Layer and Macular Normative Databases, Model 4000Carl Zeiss Meditec, Inc.2009292
+1K080460Spectral Oct/SloOpko Health, Inc.20084—
+1K063343Bioptigen Spectral Domain Ophthalmic Imaging SystemBioptigen, Inc.200670—
+2K173707P200TEOptos Plc.20183—
+2K121622Nidek RS-3000Nidek Co., Ltd.20131—
+2K121739Ivue with Normative DatabaseOptovue, Inc.2013143
+2K112184Cirrus PhotoCarl Zeiss Meditec, Inc.201213—
+2K120057Envisu Spectral Domain Ophthalmic Imaging System (Sdois)Bioptigen, Inc.20126—
+2K120238Rtvue XR OctOptovue, Inc.201217—
+2K111157CIRRUS HD-OCT WITH RETINAL NERVE FIBER LAYER, MACULAR, OPTIC NERVE HEAD, and GANGLION…Carl Zeiss Meditec, Inc.201224—
+2K093213Guided Progression Analysis on the Humphrey Field Analyzer II and II -I SeriesCarl Zeiss Meditec, Inc.20103—
+2K071250CA, Model: CamOptovue, Inc.200764—
+3K241163SPECTRALIS with Flex ModuleHeidelberg Engineering GmbH20241—
+3K233602P200TE (A10700)Optos Plc.20240—
+3K231673P200TE (A10700)Optos Plc.20231—
+3K190732P200TxEOptos Plc.20190—
+3K180229RESCAN 700, CALLISTO eyeCarl Zeiss Meditec, AG20191—
+3K163195PrimusCarl Zeiss Suzhou Co., Ltd.20170—
+3K163475iVueOptovue, Inc.20170—
+3K1615093D OCT-1 MaestroTopcon Corporation20168—
+3K153080RTVue XR OCT Avanti with AngioVue SoftwareOptovue, Inc.201616—
+3K150722EnFocus 2300, EnFocus 4400Bioptigen, Inc.20151—
+3K150977Cirrus HD-OctCarl Zeiss Meditec, Inc.201511—
+3K150467Retina WorkplaceCarl Zeiss Meditec, AG20153—
+3K142953OCT-CameraOptomedical Technologies GmbH201512
+3K141844Rescan 700, Callisto EyeCarl Zeiss Meditec, AG20145—
+3K141297Forum Glaucoma WorkplaceCarl Zeiss Meditec, AG20141—
+3K133217Cirrus PhotoCarl Zeiss Meditec, AG20143—
+3K133892IVUE 500Optovue, Inc.201402
+3K132323RS-3000 AdvanceNidek Co., Ltd.20140—
+3K130648Forum Glaucoma WorkplaceCarl Zeiss Meditec, AG20132—
+3K130656IfusionOptovue, Inc.201301
+3K113129Spectralis Anterior Segment Module (Spectralis Asm)Heidelberg Engineering GmbH20110—
+3K111505Rtvue Cam with Corneal Power UpgradeOptovue, Inc.201181
+3K100861R T Vue with Software 5.0 Model: R I Vue 100Optovue, Inc.20100—
+3K091404Ivue, Model 100Optovue, Inc.2010162
+4K253837SPECTRALIS HRA+OCT and variants; SPECTRALIS with Flex ModuleHeidelberg Engineering GmbH20260—
+4K233421Rescan 700Carl Zeiss Meditec, AG20240—
+4K200516OCT-Camera ID 21101A3Optomedical Technologies GmbH20200—
+4K200954Glaucoma ModuleTopcon Healthcare Solutions, Inc.20200—
+4K182942Canon OCT-A1Canon, Inc.20190—
+4K181534Cirrus HD-OctCarl Zeiss Meditec, Inc.201962
+4K182318Retina WorkplaceCarl Zeiss Meditec, Inc.20180—
+4K181594Spectralis HRA+OCT and variants with OCT Angiography ModuleHeidelberg Engineering GmbH201882
+4K180858CALLISTO eyeCarl Zeiss Meditec, AG20182—
+4K180660AvantiOptovue, Inc.20185—
+4K173119DRI OCT TritonTopcon Corporation20180—
+4K171370IMAGEnet 6 Ophthalmic Data SystemTopcon Corporation201731
+4K170638Retina WorkplaceCarl Zeiss Meditec, AG20172—
+4K1701643D OCT-1 MaestroTopcon Corporation20175—
+4K162783EnFocus 2300, EnFocus 4400Bioptigen, Inc.20160—
+4K161194PLEX Elite 9000 SS-OCTCarl Zeiss Meditec, Inc.201671
+4K103266IstandOptovue, Inc.20110—
+5K2410813D OPTICAL COHERENCE TOMOGRAPHY 3D OCT-1 (type: Maestro2); IMAGEnet6 Ophthalmic Data…Topcon Corporation20241—
+5K231760HP-Oct (HP-Oct)Cylite Pty., Ltd.20241—
+5K232828IMAGEnet6 Ophthalmic Data SystemTopcon Corporation202421
+5K2312223D OPTICAL COHERENCE TOMOGRAPHY 3D OCT-1(type: Maestro2)Topcon Corporation20233—
+5K231676CALLISTO eyeCarl Zeiss Meditec, AG20231—
+5K222200Cirrus HD-OctCarl Zeiss Meditec, Inc.20231—
+5K221320Scanning Laser Ophthalmoscope Mirante [SLO/OCT Model] with Image Filing Software…Nidek Co., Ltd.20230—
+5K222166SOLIXOptovue, Inc.20221—
+5K213265Tomey Cornea/Anterior Segment OCT CASIA2Tomey Corporation20221—
+5K181501AfinaNeurovision Imaging, LLC20180—
+5K182569Spectralis HRA+OCT and variants with High Magnification ModuleHeidelberg Engineering GmbH20187—
+6K253893Harmony Referral System with Harmony OCT Viewer (Octave)Topcon Healthcare Solutions EMEA Oy20260—
+6K251848Pentacam® Cornea OCTOculus Optikgeräte GmbH20260—
+6K252633Unity DX (Udx)Cylite Pty., Ltd.20250—
+6K250553Tomey Cornea/Anterior Segment OCT (CASIA2)Tomey Corporation20250—
+6K233933CIRRUS™ HD-OCT Model 6000Carl Zeiss Meditec, Inc.20240—
+6K2335613D Optical Coherence Tomography (3D OCT-1(type: Maestro2))Topcon Corporation20242—
+6K232944CALLISTO eyeCarl Zeiss Meditec, AG20230—
+6K192391Spectralis HRA+OCT and VariantsHeidelberg Engineering GmbH20196—
+7K201252Spectralis HRA+OCT and variantsHeidelberg Engineering GmbH20205—
+8K223557SPECTRALIS HRA+OCT and variantsHeidelberg Engineering GmbH20234—
+9K240221SPECTRALIS HRA+OCT and variantsHeidelberg Engineering GmbH20242—
+10K250868SPECTRALIS HRA+OCT and variantsHeidelberg Engineering GmbH20251—