510(k) Report

Devices descending from K051789

72 later devices reach Visante Oct through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K211817AnterionHeidelberg Engineering GmbH20213—
+1K150977Cirrus HD-OctCarl Zeiss Meditec, Inc.201511—
+1K083291Cirrus HD-Oct with Retinal Nerve Fiber Layer and Macular Normative Databases, Model 4000Carl Zeiss Meditec, Inc.2009292
+1K071250CA, Model: CamOptovue, Inc.200764—
+2K230897AnterionHeidelberg Engineering GmbH20232—
+2K181534Cirrus HD-OctCarl Zeiss Meditec, Inc.201962
+2K182318Retina WorkplaceCarl Zeiss Meditec, Inc.20180—
+2K170638Retina WorkplaceCarl Zeiss Meditec, AG20172—
+2K161194PLEX Elite 9000 SS-OCTCarl Zeiss Meditec, Inc.201671
+2K121622Nidek RS-3000Nidek Co., Ltd.20131—
+2K112184Cirrus PhotoCarl Zeiss Meditec, Inc.201213—
+2K111157CIRRUS HD-OCT WITH RETINAL NERVE FIBER LAYER, MACULAR, OPTIC NERVE HEAD, and GANGLION…Carl Zeiss Meditec, Inc.201224—
+2K113129Spectralis Anterior Segment Module (Spectralis Asm)Heidelberg Engineering GmbH20110—
+2K111505Rtvue Cam with Corneal Power UpgradeOptovue, Inc.201181
+2K101505Rtvue Model Rtvue 100Optovue, Inc.2010581
+2K100861R T Vue with Software 5.0 Model: R I Vue 100Optovue, Inc.20100—
+2K091404Ivue, Model 100Optovue, Inc.2010162
+2K093213Guided Progression Analysis on the Humphrey Field Analyzer II and II -I SeriesCarl Zeiss Meditec, Inc.20103—
+3K240924AnterionHeidelberg Engineering GmbH20241—
+3K2410813D OPTICAL COHERENCE TOMOGRAPHY 3D OCT-1 (type: Maestro2); IMAGEnet6 Ophthalmic Data…Topcon Corporation20241—
+3K231760HP-Oct (HP-Oct)Cylite Pty., Ltd.20241—
+3K222200Cirrus HD-OctCarl Zeiss Meditec, Inc.20231—
+3K180229RESCAN 700, CALLISTO eyeCarl Zeiss Meditec, AG20191—
+3K181501AfinaNeurovision Imaging, LLC20180—
+3K180660AvantiOptovue, Inc.20185—
+3K163195PrimusCarl Zeiss Suzhou Co., Ltd.20170—
+3K150467Retina WorkplaceCarl Zeiss Meditec, AG20153—
+3K141844Rescan 700, Callisto EyeCarl Zeiss Meditec, AG20145—
+3K141297Forum Glaucoma WorkplaceCarl Zeiss Meditec, AG20141—
+3K133217Cirrus PhotoCarl Zeiss Meditec, AG20143—
+3K132323RS-3000 AdvanceNidek Co., Ltd.20140—
+3K130648Forum Glaucoma WorkplaceCarl Zeiss Meditec, AG20132—
+3K121739Ivue with Normative DatabaseOptovue, Inc.2013143
+3K120238Rtvue XR OctOptovue, Inc.201217—
+3K103266IstandOptovue, Inc.20110—
+4K261019AnterionHeidelberg Engineering GmbH20260—
+4K253893Harmony Referral System with Harmony OCT Viewer (Octave)Topcon Healthcare Solutions EMEA Oy20260—
+4K252633Unity DX (Udx)Cylite Pty., Ltd.20250—
+4K233933CIRRUS™ HD-OCT Model 6000Carl Zeiss Meditec, Inc.20240—
+4K233602P200TE (A10700)Optos Plc.20240—
+4K233421Rescan 700Carl Zeiss Meditec, AG20240—
+4K231673P200TE (A10700)Optos Plc.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—
+4K200954Glaucoma ModuleTopcon Healthcare Solutions, Inc.20200—
+4K180858CALLISTO eyeCarl Zeiss Meditec, AG20182—
+4K163475iVueOptovue, Inc.20170—
+4K1615093D OCT-1 MaestroTopcon Corporation20168—
+4K153080RTVue XR OCT Avanti with AngioVue SoftwareOptovue, Inc.201616—
+4K133892IVUE 500Optovue, Inc.201402
+4K130656IfusionOptovue, Inc.201301
+5K251848Pentacam® Cornea OCTOculus Optikgeräte GmbH20260—
+5K250553Tomey Cornea/Anterior Segment OCT (CASIA2)Tomey Corporation20250—
+5K231676CALLISTO eyeCarl Zeiss Meditec, AG20231—
+5K182942Canon OCT-A1Canon, Inc.20190—
+5K181594Spectralis HRA+OCT and variants with OCT Angiography ModuleHeidelberg Engineering GmbH201882
+5K173119DRI OCT TritonTopcon Corporation20180—
+5K171370IMAGEnet 6 Ophthalmic Data SystemTopcon Corporation201731
+5K1701643D OCT-1 MaestroTopcon Corporation20175—
+6K232828IMAGEnet6 Ophthalmic Data SystemTopcon Corporation202421
+6K232944CALLISTO eyeCarl Zeiss Meditec, AG20230—
+6K2312223D OPTICAL COHERENCE TOMOGRAPHY 3D OCT-1(type: Maestro2)Topcon Corporation20233—
+6K182569Spectralis HRA+OCT and variants with High Magnification ModuleHeidelberg Engineering GmbH20187—
+7K2335613D Optical Coherence Tomography (3D OCT-1(type: Maestro2))Topcon Corporation20242—
+7K192391Spectralis HRA+OCT and VariantsHeidelberg Engineering GmbH20196—
+8K201252Spectralis HRA+OCT and variantsHeidelberg Engineering GmbH20205—
+9K223557SPECTRALIS HRA+OCT and variantsHeidelberg Engineering GmbH20234—
+10K241163SPECTRALIS with Flex ModuleHeidelberg Engineering GmbH20241—
+10K240221SPECTRALIS HRA+OCT and variantsHeidelberg Engineering GmbH20242—
+11K253837SPECTRALIS HRA+OCT and variants; SPECTRALIS with Flex ModuleHeidelberg Engineering GmbH20260—
+11K250868SPECTRALIS HRA+OCT and variantsHeidelberg Engineering GmbH20251—