Data / Medical devices / Japan / Fair Medical Co.,ltd
Fair Medical Co.,ltd: FDA-registered device maker in Kashiwa Chiba, Japan, 2 510(k) clearances
Fair Medical Co.,ltd is registered with the FDA (registration 3011825597) in Kashiwa Chiba, Japan. It lists 4 device types. The FDA files 2 510(k) clearances under its listings, the newest dated June 2, 2008. Registered through 2026. FDA data exported November 3, 2026.
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- FDA registration number
- 3011825597
- Address
- 1215 Izumi, Kashiwa Chiba, Japan, 270-1456
- Owner or operator
- Fair Medical Co.,Ltd (10081825)
- Roles
- Exporter to the US
- First device listed
- May 19, 2021
- Registered through
- 2026
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Solid State X-Ray Imager (Flat Panel/Digital Imager) | MQB | 2 | Exporter to the US | accessdata.fda.gov |
| System, X-Ray, Stationary | KPR | 2 | Exporter to the US | accessdata.fda.gov |
| System, X-Ray, Tomographic | IZF | 2 | Exporter to the US | accessdata.fda.gov |
| System, X-Ray, Tomography, Computed | JAK | 2 | Exporter to the US | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| June 2, 2008 | K081022 | SOMATOM DEFINITION, MODEL AS/AS+ | JAK | Substantially Equivalent | Siemens Medical Solutions USA, Inc. | accessdata.fda.gov |
| August 9, 2005 | K051967 | REVOLUTION XR/D DIGITAL RADIOGRAPHIC IMAGING SYSTEM WITH TOMOSYNTHESIS | KPR | Substantially Equivalent | GE Healthcare | accessdata.fda.gov |
Compare with other makers
- All makers of System, X-Ray, Tomography, Computed
- All makers of System, X-Ray, Stationary
- All makers of Solid State X-Ray Imager (Flat Panel/Digital Imager)
- All makers of System, X-Ray, Tomographic
Updated June 2, 2008. 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.