Data / Medical devices / Interventional Fluoroscopic X-Ray System / Japan
FDA-registered makers of Interventional Fluoroscopic X-Ray System in Japan: 8 establishments
8 establishments in Japan are registered with the FDA to make Interventional Fluoroscopic X-Ray System (product code OWB). 8 have a 510(k) clearance or PMA approval on file and 1 has a recall event. FDA data exported November 2, 2026.
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- Device
- Interventional Fluoroscopic X-Ray System
- Product code
- OWB
- Country
- Japan
Makers of Interventional Fluoroscopic X-Ray System in Japan
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Canon Inc. | OTAWARA-SHI Tochigi, Japan | Manufacturer | 26 | March 10, 2026 | 0 | 0 | 0 | api.fda.gov |
| Canon Inc. | OHTA-KU Tokyo, Japan | Specification developer | 26 | March 10, 2026 | 0 | 0 | 0 | api.fda.gov |
| Shimadzu Corporation Medical Systems Division | Kyoto, Japan | Complaint file establishment, Manufacturer | 4 | March 24, 2026 | 0 | 2 | 0 | api.fda.gov |
| Canon Components, Inc. | KODAMA-GUN Saitama, Japan | Manufacturer | 2 | June 7, 2012 | 0 | 0 | 0 | api.fda.gov |
| Canon Inc. | Kawasaki Kanagawa, Japan | Specification developer | 2 | June 7, 2012 | 0 | 0 | 0 | api.fda.gov |
| Canon.Inc | OHTA-KU Tokyo, Japan | Specification developer | 2 | June 7, 2012 | 0 | 0 | 0 | api.fda.gov |
| Fujifilm Corporation | ASHIGARAKAMI-GUN Kanagawa, Japan | Manufacturer | 1 | November 8, 2021 | 0 | 0 | 0 | api.fda.gov |
| FUJIFILM Healthcare Manufacturing Corporation Hanamaki Office | HANAMAKI-SHI Iwate, Japan | Manufacturer | 1 | November 8, 2021 | 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.