510(k) Report

Devices descending from K954780

40 later devices reach Kowa Professional Fundus Camera Models FX-500, FX-500S, FX-500C through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K062416Retinal Functional Imager (Rfi)Optical Imaging, Ltd.20063—
+1K043213Kowa VX-10Kowa Co., Ltd.200531—
+1K974535Discam Digital Imaging SystemMarcher Enterprises, Ltd.19983—
+2K153239LSFG-NaviSoftcare Co., Ltd.20160—
+2K102412Vista Digital OpthalmoscopeEyequick.Llc20112—
+2K100207Non-Mydriatic Retinal Camera, Model TRC-NW8FTopcon Corp.201028—
+2K090115Retina Camera TRC-NW7SF Mark IITopcon Corp.200930—
+2K080180Modification to Retinal Function Imager (Rfi)Optical Imaging, Ltd.20081—
+3K193319XyCAM RI, XyCAM RI System, XyCAM Retinal Imaging SystemVasoptic Medical, Inc.20200—
+3K141325TRC-NW8F Plus Non-Mydriatic Retinal CameraTopcon Corp.20140—
+3K123101TRC-50DX Retinal CameraTopcon Medical Systems, Inc.20132—
+3K130289TRC-NW8 Non-Mydriatic Retinal CameraTopcon Corp.20130—
+3K123460TRC-NW300 Non-Mydriatic Retinal CameraTopcon Medical Systems, Inc.201311—
+3K121405PanopticWelch Allyn, Inc.20121—
+3K112184Cirrus PhotoCarl Zeiss Meditec, Inc.201213—
+4K223381iExaminer System with Panoptic PlusWelch Allyn, Inc.20230—
+4K180229RESCAN 700, CALLISTO eyeCarl Zeiss Meditec, AG20191—
+4K173119DRI OCT TritonTopcon Corporation20180—
+4K1615093D OCT-1 MaestroTopcon Corporation20168—
+4K150467Retina WorkplaceCarl Zeiss Meditec, AG20153—
+4K141844Rescan 700, Callisto EyeCarl Zeiss Meditec, AG20145—
+4K141297Forum Glaucoma WorkplaceCarl Zeiss Meditec, AG20141—
+4K141481TRC-NW400 Non-Mydriatic Retinal CameraTopcon Corporation20141—
+4K133217Cirrus PhotoCarl Zeiss Meditec, AG20143—
+5K233421Rescan 700Carl Zeiss Meditec, AG20240—
+5K221111Non-Mydriatic Retinal Camera NW500Topcon Corporation20220—
+5K200954Glaucoma ModuleTopcon Healthcare Solutions, Inc.20200—
+5K182318Retina WorkplaceCarl Zeiss Meditec, Inc.20180—
+5K180858CALLISTO eyeCarl Zeiss Meditec, AG20182—
+5K171370IMAGEnet 6 Ophthalmic Data SystemTopcon Corporation201731
+5K170638Retina WorkplaceCarl Zeiss Meditec, AG20172—
+5K1701643D OCT-1 MaestroTopcon Corporation20175—
+6K232828IMAGEnet6 Ophthalmic Data SystemTopcon Corporation202421
+6K2312223D OPTICAL COHERENCE TOMOGRAPHY 3D OCT-1(type: Maestro2)Topcon Corporation20233—
+6K231676CALLISTO eyeCarl Zeiss Meditec, AG20231—
+6K181501AfinaNeurovision Imaging, LLC20180—
+7K2410813D OPTICAL COHERENCE TOMOGRAPHY 3D OCT-1 (type: Maestro2); IMAGEnet6 Ophthalmic Data…Topcon Corporation20241—
+7K2335613D Optical Coherence Tomography (3D OCT-1(type: Maestro2))Topcon Corporation20242—
+7K232944CALLISTO eyeCarl Zeiss Meditec, AG20230—
+8K253893Harmony Referral System with Harmony OCT Viewer (Octave)Topcon Healthcare Solutions EMEA Oy20260—