FDA 510(k) Premarket Notification K041546: DIGITAL FUNDUS CAMERA, MODEL CF-60DSI

Submission Details & Decision

Normalized public record details for 510(k) notification K041546.

Source Dataset

FDA 510(k) Premarket Notifications

510(k) Number

K041546

Applicant / Sponsor

Canon, Inc.

Device Name

DIGITAL FUNDUS CAMERA, MODEL CF-60DSI

Product Code

HKI

Decision Date

2004-06-23

Decision / Status

Substantially Equivalent (SESE)

Advisory Committee

Ophthalmic (OP)

Clearance Type

Traditional

Third Party Flag

Date Received

2004-06-09

Related Establishments / Registrations

CANON INC. Registration: 1000181430 View Registration
KEELER LTD. Registration: 1000391004 View Registration
TOYO MEDICAL CO. Registration: 1054713 View Registration
PRECISION OPTICS CORP. Registration: 1222616 View Registration
WELCH ALLYN, INC. Registration: 1316463 View Registration
REICHERT INC. Registration: 1319721 View Registration
VOLK OPTICAL INC. Registration: 1528142 View Registration
JEDMED Instrument Company Registration: 1926681 View Registration
KARL STORZ ENDOSCOPY-AMERICA, INC. Registration: 2020550 View Registration
KARL STORZ IMAGING, INC. Registration: 2027009 View Registration
Kowa Pharmaceuticals America, Inc. Registration: 2080939 View Registration
Topcon Healthcare, Inc. Registration: 2242863 View Registration
ISCREEN VISION INC. Registration: 2320749 View Registration
ACCUTOME, INC. Registration: 2521877 View Registration
CARL ZEISS MEDITEC INC Registration: 2918630 View Registration
NIDEK INCORPORATED Registration: 2936921 View Registration
NIDEK CO., LTD. HAMACHO PLANT Registration: 3002807715 View Registration
SPARTRONICS STRONGSVILLE, INC. Registration: 3003144120 View Registration
MIDWEST PRODUCTS AND ENGINEERING Registration: 3003500271 View Registration
VISIONIX LTD. Registration: 3003771740 View Registration
CANON COMPONENTS, INC. Registration: 3004026651 View Registration
S4OPTIK LLC Registration: 3004441848 View Registration
Rodenstock (Thailand) Co., Ltd. Registration: 3004443844 View Registration
Industria Optica Rodenstock Chile S. A Registration: 3004848970 View Registration
SHANGHAI MEDIWORKS PRECISION INSTRUMENTS CO., LTD. Registration: 3005755367 View Registration
TAIZHOU CITY K&W INTERNATIONAL TRADE CO.,LTD. Registration: 3005785090 View Registration
OPTOVUE, INC. Registration: 3005950902 View Registration
WELCH ALLYN DE MEXICO, S. DE R.L. DE C.V. Registration: 3006087789 View Registration
FABRINET CO., LTD. Registration: 3006546174 View Registration
FUNDUS PHOTO Registration: 3007237389 View Registration
Optomed Registration: 3007710608 View Registration
VISIA imaging S.r.l. Registration: 3007913988 View Registration
TearScience, Inc. Registration: 3008169506 View Registration
OD-OS GMBH Registration: 3008252121 View Registration
RODENSTOCK CR S.R.O. Registration: 3008396732 View Registration
Topcon Yamagata Co., LTD Registration: 3008729548 View Registration
LUNEAU TECHNOLOGY OPERATIONS Registration: 3009173773 View Registration
CARL ZEISS MEDITEC AG (Munich) Registration: 3009746052 View Registration
TAISHODO VIETNAM CO., LTD. Registration: 3009990264 View Registration
CRYSTALVUE MEDICAL CORPORATION Registration: 3010000450 View Registration
Rodenstock GmbH Registration: 3010069263 View Registration
Karl Storz Endoscopy-America, Inc. Registration: 3010202439 View Registration
CLASSYS INC Registration: 3010363436 View Registration
MW.FEP SPA Registration: 3010394097 View Registration
SOFTCARE CO., LTD. Registration: 3010792309 View Registration
KOWA CO. LTD. CHOFU Registration: 3011223751 View Registration
Phoenix Technology Group LLC Registration: 3012096560 View Registration
FORUS HEALTH PVT.LTD., Registration: 3012162565 View Registration
FedEx Supply Chain, Inc. Registration: 3013403214 View Registration
KARL STORZ SE & CO KG Registration: 3014342096 View Registration
OPTINA DIAGNOSTICS INC. Registration: 3014606890 View Registration
MEDIMAGING INTEGRATED SOLUTION INC. Registration: 3015316279 View Registration
INNOVA MEDICAL OPHTHALMICS Registration: 3015972897 View Registration
CHONGQING BIO NEWVISION MEDICAL EQUIPMENT LTD. Registration: 3016589969 View Registration
PHELCOM TECHNOLOGIES Registration: 3017175640 View Registration
CARL ZEISS MEDITEC AG (JENA) Registration: 3038356864 View Registration
Canon.Inc Registration: 3038614464 View Registration
OPTAIN HEALTH Registration: 3038790635 View Registration
RUDOLF RIESTER GMBH Registration: 8010482 View Registration
C.S.O. S.R.L. Registration: 8020986 View Registration
NIDEK CO., LTD. Registration: 8030392 View Registration
Natus Medical Denmark ApS Registration: 9612197 View Registration
TOPCON CORP. Registration: 9614661 View Registration
Carl Zeiss Meditec AG (Jena) Registration: 9615030 View Registration
HUVITZ CO., LTD. Registration: 9616199 View Registration
CARL ZEISS VISION GMBH Registration: 9617474 View Registration

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