FDA 510(k) Applications for Medical Device:
System, Image Management, Ophthalmic
| FDA 510(k) Number | Applicant | Address | City / Country | State / Province | Postal Code |
|---|---|---|---|---|---|
| K232088 | Altris, Inc. |
125 South Clark Street, 17th Floor | Chicago | IL | 60603 |
| K201273 | Canon Inc. |
9-1, Imaikami-cho | Nakahara-ku, Kawasaki | 211-8501 | |
| K173689 | Canon Inc. -Medical Equipment Group |
9-1, Imaikami-cho, | Nakahara-ku, Kawasaki | 211-8501 | |
| K123464 | CARL ZEISS MEDITEC AG |
5160 HACIENDA DRIVE | DUBLIN | CA | 94568 |
| K180858 | Carl Zeiss Meditec AG |
Goeschwitzer Str. 51-52 | Jena | 07745 | |
| K231676 | Carl Zeiss Meditec AG |
Goeschwitzer Strasse 51-52 | Jena | 07745 | |
| K213527 | Carl Zeiss Meditec AG |
Goeschwitzer Strasse 51-52 | Jena | 07745 | |
| K122938 | CARL ZEISS MEDITEC AG |
5160 HACIENDA DRIVE | DUBLIN | CA | 94568 |
| K130648 | CARL ZEISS MEDITEC AG |
5160 HACIENDA DRIVE | DUBLIN | CA | 94568 |
| K141297 | CARL ZEISS MEDITEC AG |
5160 HACIENDA DRIVE | DUBLIN | CA | 94568 |
| K150467 | CARL ZEISS MEDITEC AG |
GOESCHWITZER STR. 51-52 | JENA | 07745 | |
| K170638 | Carl Zeiss Meditec AG |
Goeschwitzer strasse 51-52 | Jena | 07745 | |
| K182318 | Carl Zeiss Meditec, Inc |
5160 Hacienda Drive | Dublin | CA | 94568 |
| K090439 | CARL ZEISS MEDITEC, INC. |
5160 HACIENDA DRIVE | DUBLIN | CA | 94568 |
| K110869 | DIAGNOS, INC |
300 BRICKSTONE SQUARE | ANDOVER | MA | 01810 |
| K071299 | DIGITAL HEALTHCARE, LTD. |
343 SOUTH WHITE ST. | WAKE FOREST | NC | 27587 |
| K090266 | EYEIC CORPORATION |
1920 ARLINGTON PLACE | MADISON | WI | 53726-4002 |
| K130453 | EYEKOR, LLC. |
5 TIMBER LANE | NORTH READING | MA | 01864 |
| K142423 | HAAG-STREIT AG |
GARDENSTADTSTRASSE 10 | KOENIZ, BERN | CH-3098 | |
| K191615 | Huvitz Co., Ltd. |
38, Burim-ro, 170beon-gil, Dongan-gu | Anyang-si, Dongan-gu | 14055 | |
| K161829 | HUVITZ CO., LTD. |
GONGDAN-RO | GUNPO-SI | 435-862 | |
| K200385 | Integrated Ophthalmic Systems, Inc. |
596 Main Street | Woburn | MA | 01801 |
| K141922 | INTELLIGENT RETINAL IMAGING SYSTEMS, LLC |
300 BRICKSTONE SQUARE | ANDOVER | MA | 01810 |
| K203244 | Konan Medical, Inc. |
10-29, Miyanishicho | Nishinomiya | 662-0976 | |
| K081797 | KONAN MEDICAL, INC. |
377 ROUTE 17 SOUTH | HASBROUCK HEIGHTS | NJ | 07604 |
| K190056 | KOWA Co. Ltd. CHOFU |
3-1, Chofugaoka 3-chome | Chofu | 182-0021 | |
| K220929 | Merit CRO, Inc. |
6527 Normandy Lane, Suite 100 | Madison | WI | 53719 |
| K181501 | NeuroVision Imaging, LLC |
1395 Garden Highway, Suite 250 | Sacramento | CA | 95833 |
| K181345 | Nidek Co., Ltd |
34-14 Maehama | Hiroishi-cho Gamagori | 443-0038 | |
| K013694 | NIDEK, INC. |
21911 ERIE LN. | LAKE FOREST | CA | 92630 |
| K110006 | OPHTHALMIC IMAGING SYSTEMS |
221 LATHROP WAY, SUITE I | SACRAMENTO | CA | 95815 |
| K200275 | Ophthalmic Labs, Inc. |
18 Berlin Ave | Milton | MA | 02186 |
| K113696 | OPTOS PLC |
555 13TH STREET, NW | WASHINGTON | DC | 20004 |
| K162039 | Optos Plc |
Queensferry House, Carnegie Campus, Enterprise Way | Dunfermline | KY11 8GR | |
| K211715 | RetinAI Medical AG |
Freiburgstrasse, 3 | Bern | 3010 | |
| K171098 | Sonomed, Inc. |
1979 Marcus Ave, Suite C105 | New Hyde Park | NY | 11042 |
| K082364 | TOPCON CORP. |
310 TERRACE AVENUE | CINCINNATI | OH | 45220 |
| K171370 | Topcon Corporation |
75-1 Hasunuma-Cho, Itabashi-Ku | Tokyo | 174-8580 | |
| K210396 | Topcon Healthcare Solutions EMEA Oy |
Makelininkatu 43 | Oulu | 90100 | |
| K200954 | Topcon Healthcare Solutions, Inc. |
111 Bauer Drive | Oakland | NJ | 07436 |
| K182376 | Topcon Medical Systems, Inc. |
111 Bauer Drive | Oakland | NJ | 07436 |
| K132438 | TOPCON MEDICAL SYSTEMS, INC. |
5 TIMBER LANE | NORTH READING | MA | 01864 |
| K093313 | TOPCON MEDICAL SYSTEMS, INC. |
5 TIMBER LANE | NORTH READING | MA | 01864 |
| K151952 | TOPCON MEDICAL SYSTEMS, INC. |
111 BAUER DR | OAKLAND | NJ | 07436 |
| K132667 | TOPCON MEDICAL SYSTEMS, INC. |
5 TIMBER LANE | NORTH READING | MA | 01864 |
| K200422 | VisionQuest BioMedical, Inc. |
2501 Yale Blvd SE #301 | Albuquerque | NM | 87106 |
| K181016 | Welch Allyn, Inc. |
4341 State Street Rd. | Skaneateles Falls | NY | 13153 |
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