Data / Medical devices / System, X-Ray, Angiographic / Japan
FDA-registered makers of System, X-Ray, Angiographic in Japan: 10 establishments
10 establishments in Japan are registered with the FDA to make System, X-Ray, Angiographic (product code IZI). 5 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, X-Ray, Angiographic
- Product code
- IZI
- Country
- Japan
Makers of System, X-Ray, Angiographic in Japan
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Shimadzu Corporation Medical Systems Division | Kyoto, Japan | Contract manufacturer, Manufacturer | 7 | August 31, 2007 | 0 | 0 | 0 | api.fda.gov |
| Everx Japan Co. Ltd | Kawasaki Kanagawa, Japan | Exporter to the US, Remanufacturer, Repackager or relabeler | 1 | May 21, 2013 | 0 | 0 | 0 | api.fda.gov |
| Hamamatsu Photonics K.K., Systems Division | HAMAMATSU CITY Shizuoka, Japan | Complaint file establishment, Manufacturer | 1 | March 27, 2014 | 0 | 0 | 0 | api.fda.gov |
| Olympus Medical Systems Corp. | HACHIOJI-SHI Tokyo, Japan | Specification developer | 1 | October 10, 2019 | 0 | 0 | 0 | api.fda.gov |
| OLYMPUS MEDICAL SYSTEMS CORP. Hinode Plant | NISHITAMA-GUN Tokyo, Japan | Manufacturer | 1 | October 10, 2019 | 0 | 0 | 0 | api.fda.gov |
| Canon Components, Inc. | KODAMA-GUN Saitama, Japan | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Canon Inc. | OTAWARA-SHI Tochigi, 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 | |
| Canon.Inc | OHTA-KU Tokyo, Japan | Specification developer | 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.