Data / Medical devices / System, Image Processing, Radiological / Japan
FDA-registered makers of System, Image Processing, Radiological in Japan: 13 establishments
13 establishments in Japan are registered with the FDA to make System, Image Processing, Radiological (product code LLZ). 12 have a 510(k) clearance or PMA approval on file and 0 have a recall event. FDA data exported November 2, 2026.
SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.
- Device
- System, Image Processing, Radiological
- Product code
- LLZ
- Country
- Japan
Makers of System, Image Processing, Radiological 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 | 12 | November 10, 2022 | 0 | 0 | 0 | api.fda.gov |
| FUJIFILM Corporation Medical Systems Research & Development Center Minamiaoyama | Minato Tokyo, Japan | Manufacturer | 11 | November 10, 2022 | 0 | 0 | 0 | api.fda.gov |
| Canon Inc. | OTAWARA-SHI Tochigi, Japan | Manufacturer | 9 | July 17, 2024 | 0 | 0 | 0 | api.fda.gov |
| Canon Inc. | OHTA-KU Tokyo, Japan | Specification developer | 9 | July 17, 2024 | 0 | 0 | 0 | api.fda.gov |
| Konica Minolta Technoproducts Co., Ltd. | SAYAMA-SHI Saitama, Japan | Manufacturer | 8 | May 31, 2024 | 0 | 0 | 0 | api.fda.gov |
| Konica Minolta, Inc. | HINO-SHI Tokyo, Japan | Complaint file establishment, Specification developer | 8 | May 31, 2024 | 0 | 0 | 0 | api.fda.gov |
| Konica Minolta, Inc. | HACHIOJI-SHI Tokyo, Japan | Specification developer | 5 | May 31, 2024 | 0 | 0 | 0 | api.fda.gov |
| Eizo Corporation | HAKUSAN Ishikawa, Japan | Manufacturer | 4 | July 3, 2013 | 0 | 0 | 0 | api.fda.gov |
| Ziosoft, Inc. | Minato-ku Tokyo, Japan | Manufacturer | 3 | May 5, 2020 | 0 | 0 | 0 | api.fda.gov |
| Cardio Flow Design Inc. | Tokyo, Japan | Manufacturer | 1 | May 12, 2023 | 0 | 0 | 0 | api.fda.gov |
| FUJIFILM Healthcare Manufacturing Corporation Hanamaki Office | HANAMAKI-SHI Iwate, Japan | Exporter to the US, Manufacturer | 1 | November 10, 2022 | 0 | 0 | 0 | api.fda.gov |
| J. Morita MFG. Corp. | FUSHIMI-KU Kyoto, Japan | Manufacturer | 1 | February 21, 2008 | 0 | 0 | 0 | api.fda.gov |
| Shimadzu Corporation Medical Systems Division | Kyoto, 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.