Data / Medical devices / Automated Radiological Image Processing Software / Japan
FDA-registered makers of Automated Radiological Image Processing Software in Japan: 7 establishments
7 establishments in Japan are registered with the FDA to make Automated Radiological Image Processing Software (product code QIH). 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
- Automated Radiological Image Processing Software
- Product code
- QIH
- Country
- Japan
Makers of Automated Radiological Image Processing Software in Japan
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Fujifilm Corporation | ASHIGARAKAMI-GUN Kanagawa, Japan | Complaint file establishment, Manufacturer | 2 | April 30, 2026 | 0 | 0 | 0 | api.fda.gov |
| FUJIFILM Corporation Medical Systems Research & Development Center Minamiaoyama | Minato Tokyo, Japan | Manufacturer | 2 | April 30, 2026 | 0 | 0 | 0 | api.fda.gov |
| FUJIFILM Healthcare Manufacturing Corporation Hanamaki Office | HANAMAKI-SHI Iwate, Japan | Manufacturer | 2 | April 30, 2026 | 0 | 0 | 0 | api.fda.gov |
| Canon Inc. | OTAWARA-SHI Tochigi, Japan | Manufacturer | 1 | April 30, 2025 | 0 | 0 | 0 | api.fda.gov |
| Canon Inc. | OHTA-KU Tokyo, Japan | Specification developer | 1 | April 30, 2025 | 0 | 0 | 0 | api.fda.gov |
| GE Healthcare Japan Corporation | HINO-SHI Tokyo, Japan | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Shimadzu Corporation Medical Systems Division | Kyoto, Japan | Complaint file establishment, 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.