Data / Medical devices / System, X-Ray, Tomography, Computed / Japan
FDA-registered makers of System, X-Ray, Tomography, Computed in Japan: 10 establishments
10 establishments in Japan are registered with the FDA to make System, X-Ray, Tomography, Computed (product code JAK). 7 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, Tomography, Computed
- Product code
- JAK
- Country
- Japan
Makers of System, X-Ray, Tomography, Computed in Japan
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Canon Inc. | OTAWARA-SHI Tochigi, Japan | Manufacturer | 55 | May 20, 2026 | 0 | 0 | 0 | api.fda.gov |
| Canon Inc. | OHTA-KU Tokyo, Japan | Specification developer | 55 | May 20, 2026 | 0 | 0 | 0 | api.fda.gov |
| GE Healthcare Japan Corporation | HINO-SHI Tokyo, Japan | Specification developer | 13 | March 23, 2026 | 0 | 1 | 0 | api.fda.gov |
| FUJIFILM Corporation Medical Systems Research & Development Center Kashiwa | KASHIWA-SHI Chiba, Japan | Manufacturer | 8 | September 18, 2026 | 0 | 0 | 0 | api.fda.gov |
| FUJIFILM Healthcare Manufacturing Corporation Kashiwa Office | Kashiwa-shi Chiba, Japan | Manufacturer | 8 | September 18, 2026 | 0 | 0 | 0 | api.fda.gov |
| J. Morita MFG. Corp. | FUSHIMI-KU Kyoto, Japan | Manufacturer | 1 | April 9, 2008 | 0 | 0 | 0 | api.fda.gov |
| Sony Corporation | Yokohama-shi Kanagawa, Japan | Complaint file establishment, Specification developer | 1 | May 20, 1997 | 0 | 0 | 0 | api.fda.gov |
| FUJIFILM Corporation Medical Systems Research & Development Center Minamiaoyama | Minato Tokyo, Japan | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| J. Morita MFG. Corp., Tottori Factory | Kurayoshi Tottori, Japan | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ziosoft, Inc. | Minato-ku Tokyo, Japan | 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.