Data / Medical devices / Tomography, Optical Coherence / Japan
FDA-registered makers of Tomography, Optical Coherence in Japan: 8 establishments
8 establishments in Japan are registered with the FDA to make Tomography, Optical Coherence (product code OBO). 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
- Tomography, Optical Coherence
- Product code
- OBO
- Country
- Japan
Makers of Tomography, Optical Coherence in Japan
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Topcon Corp. | Tokyo, Japan | Specification developer | 8 | July 17, 2024 | 0 | 0 | 0 | api.fda.gov |
| Canon Components, Inc. | KODAMA-GUN Saitama, Japan | Manufacturer | 1 | July 24, 2019 | 0 | 0 | 0 | api.fda.gov |
| Canon Inc. | Kawasaki Kanagawa, Japan | Specification developer | 1 | July 24, 2019 | 0 | 0 | 0 | api.fda.gov |
| Canon.Inc | OHTA-KU Tokyo, Japan | Specification developer | 1 | July 24, 2019 | 0 | 0 | 0 | api.fda.gov |
| Nidek Co., Ltd. | Gamagori, Aichi, Japan | Specification developer | 1 | March 30, 2023 | 0 | 0 | 0 | api.fda.gov |
| Nidek Co., Ltd. Hamacho Plant | Gamagori, Aichi, Japan | Manufacturer | 1 | March 30, 2023 | 0 | 0 | 0 | api.fda.gov |
| Tomey Corporation | NAGOYA Aichi, Japan | Manufacturer | 1 | July 18, 2025 | 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.