Data / Medical devices / Full Field Digital, System, X-Ray, Mammographic / Japan
FDA-registered makers of Full Field Digital, System, X-Ray, Mammographic in Japan: 5 establishments
5 establishments in Japan are registered with the FDA to make Full Field Digital, System, X-Ray, Mammographic (product code MUE). 5 have a 510(k) clearance or PMA approval on file and 0 have a recall event. FDA data exported November 3, 2026.
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- Device
- Full Field Digital, System, X-Ray, Mammographic
- Product code
- MUE
- Country
- Japan
Makers of Full Field Digital, System, X-Ray, Mammographic 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 | 4 | May 27, 2022 | 1 | 0 | 0 | api.fda.gov |
| FUJIFILM Healthcare Manufacturing Corporation Hanamaki Office | HANAMAKI-SHI Iwate, Japan | Manufacturer | 4 | May 27, 2022 | 0 | 0 | 0 | api.fda.gov |
| Konica Minolta Technoproducts Co., Ltd. | SAYAMA-SHI Saitama, Japan | Manufacturer | 1 | December 23, 2011 | 0 | 0 | 0 | api.fda.gov |
| Konica Minolta, Inc. | HACHIOJI-SHI Tokyo, Japan | Specification developer | 1 | December 23, 2011 | 0 | 0 | 0 | api.fda.gov |
| Konica Minolta, Inc. | HINO-SHI Tokyo, Japan | Specification developer | 1 | December 23, 2011 | 0 | 0 | 0 | api.fda.gov |
Updated November 3, 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.