510(k) Report

Devices descending from K982057

36 later devices reach BC 900 Slit Lamp through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K110489Slit Lamp SL-2GTopcon Medical Systems, Inc.20115—
+1K100202Slit Lamp BO 900, BQ 900, BP900Haag-Streit AG201012—
+1K092374Ois Eyescan Portable Modular Imaging System, Model Ois EyescanOphthalmic Imaging Systems200922—
+2K162636Marco Ultra M3, Marco Ultra M4Takagi Seiko Co., Ltd.20170—
+2K152535Z5 Slit lamp microscope, Z2 Slit lamp microscopeTakagi Seiko Co., Ltd.20161—
+2K133667Slit Lamp SL-D701Topcon Corp.20142—
+2K140451Keeler Slit Lamp H-Series Digital (Halogen Bulb Option), Keeler Slit Lamp H-Series…Keeler Limited20142—
+2K133062Discovery SystemInnovative Visual Systems20140—
+2K131589Keeler Slit Lamp H-SeriesKeeler, Ltd.20134—
+2K101935Centervue Digital Retinography SystemCentervue S.P.A.201021—
+3K262637SLIT LAMP SL-D4 (Type: LED)Topcon Corporation20260—
+3K202221VX650Luneau Technology Operations20210—
+3K190954Fundus CameraChongqing Bio Newvision Medical Equipment, Ltd.20200—
+3K180306NexyNext Sight Srl20182—
+3K171877SLM-1ER, SLM-2ER, SLM-3ERChongqing Kanghua Ruiming S&T Co., Ltd.20170—
+3K163564Slit Lamp SL-2000Nidek Co., Ltd.20170—
+3K161972Slit Lamp SL-D301Topcon Corporation20160—
+3K151394Keeler Slit LampKeeler Limited20150—
+3K142047EIDONCentervue S.P.A.20148—
+3K122572Icam Fundus CameraOptovue, Inc.20138—
+4K250683Resolve Fundus CameraOptain Health, Inc.20250—
+4K222166SOLIXOptovue, Inc.20221—
+4K192113DRSplusCentervue S.P.A.20191—
+4K182199NFC-700 non-mydriatic auto fundus cameraCrystalvue Medical Corporation20193—
+4K180526Eidon FACentervue S.P.A.20182—
+4K180293Retia 2Centervue S.P.A.20180—
+4K150320CompassCentervue S.P.A.20151—
+4K130656IfusionOptovue, Inc.201301
+5K251848Pentacam® Cornea OCTOculus Optikgeräte GmbH20260—
+5K243504Maia (AHMACME001)Centervue S.P.A.20250—
+5K242508Verily Numetric Retinal CameraVerily Life Sciences, LLC20240—
+5K230627Zilia Ocular FC (ZIL-10002)Zilia, Inc.20230—
+5K213705DRSplusCentervue S.P.A.20210—
+5K211328Eidon FA, Eidon, Eidon AF, Eidon UwflCentervue S.P.A.20211—
+5K210197NFC-600 Automated Portable Retinal CameraCrystalvue Medical Corporation20210—
+6K241931OcuMet Beacon (OCUB100)Ocusciences, Inc.20250—