Data / Medical devices / System, X-Ray, Fluoroscopic, Image-Intensified / Japan
FDA-registered makers of System, X-Ray, Fluoroscopic, Image-Intensified in Japan: 9 establishments
9 establishments in Japan are registered with the FDA to make System, X-Ray, Fluoroscopic, Image-Intensified (product code JAA). 3 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
- System, X-Ray, Fluoroscopic, Image-Intensified
- Product code
- JAA
- Country
- Japan
Makers of System, X-Ray, Fluoroscopic, Image-Intensified in Japan
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Canon Inc. | OTAWARA-SHI Tochigi, Japan | Manufacturer | 8 | September 12, 2023 | 0 | 0 | 0 | api.fda.gov |
| Canon Inc. | OHTA-KU Tokyo, Japan | Specification developer | 8 | September 12, 2023 | 0 | 0 | 0 | api.fda.gov |
| Shimadzu Corporation Medical Systems Division | Kyoto, Japan | Complaint file establishment, Manufacturer | 5 | August 5, 2019 | 0 | 1 | 0 | api.fda.gov |
| Canon Components, Inc. | KODAMA-GUN Saitama, Japan | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Canon Inc. | Kawasaki Kanagawa, Japan | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Canon.Inc | OHTA-KU Tokyo, Japan | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Fujifilm Corporation | ASHIGARAKAMI-GUN Kanagawa, Japan | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| FUJIFILM Healthcare Manufacturing Corporation Hanamaki Office | HANAMAKI-SHI Iwate, Japan | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Shimane Shimadzu Corporation | IZUMO Shimane, 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.