Data / Medical devices / System, Image Management, Ophthalmic / Japan
FDA-registered makers of System, Image Management, Ophthalmic in Japan: 9 establishments
9 establishments in Japan are registered with the FDA to make System, Image Management, Ophthalmic (product code NFJ). 7 have a 510(k) clearance or PMA approval on file and 0 have a recall event. FDA data exported November 2, 2026.
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- Device
- System, Image Management, Ophthalmic
- Product code
- NFJ
- Country
- Japan
Makers of System, Image Management, Ophthalmic in Japan
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Topcon Corp. | Tokyo, Japan | Specification developer | 4 | March 1, 2024 | 0 | 0 | 0 | api.fda.gov |
| Canon Inc. | Kawasaki Kanagawa, Japan | Manufacturer, Specification developer | 2 | September 25, 2020 | 0 | 0 | 0 | api.fda.gov |
| Canon.Inc | OHTA-KU Tokyo, Japan | Specification developer | 2 | September 25, 2020 | 0 | 0 | 0 | api.fda.gov |
| Konan Medical, Inc. | NISHINOMIYA Hyogo, Japan | Manufacturer | 1 | June 15, 2021 | 0 | 0 | 0 | api.fda.gov |
| Kowa Co. Ltd. Chofu | Chofu Tokyo, Japan | Manufacturer | 1 | February 12, 2019 | 0 | 0 | 0 | api.fda.gov |
| Nidek Co., Ltd. | Gamagori, Aichi, Japan | Specification developer | 1 | July 19, 2018 | 0 | 0 | 0 | api.fda.gov |
| Nidek Co., Ltd. Hamacho Plant | Gamagori, Aichi, Japan | Manufacturer | 1 | July 19, 2018 | 0 | 0 | 0 | api.fda.gov |
| Canon Components, Inc. | KODAMA-GUN Saitama, Japan | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Topcon Yamagata Co., LTD | Yamagata-KEN, Japan | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated November 2, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.