Data / Medical devices / France / Thales Avs France SAS
Thales Avs France SAS: FDA-registered device maker in MOIRANS Isere, France, 2 510(k) clearances
Thales Avs France SAS is registered with the FDA (registration 3004077520) in MOIRANS Isere, France. It lists 3 device types. The FDA files 2 510(k) clearances under its listings, the newest dated September 22, 2016. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3004077520
- Address
- 460, rue du Pommarin, MOIRANS Isere, France, 38430
- Owner or operator
- Thales AVS France SAS (10067165)
- Roles
- Exporter to the US
- First device listed
- April 4, 2020
- Registered through
- 2026
- Brand names listed
- ArtPIX Mobile EZ2GO, Duet DRF
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, Fluoroscopic, Image-Intensified | JAA | 2 | Exporter to the US | accessdata.fda.gov |
| System, X-Ray, Stationary | KPR | 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 |
|---|---|---|---|---|---|---|
| September 22, 2016 | K162224 | ArtPix Mobile EZ2GO | KPR | Substantially Equivalent | Cmt Medical Technologies, Ltd. | accessdata.fda.gov |
| March 29, 2011 | K103038 | DUET DRF | JAA | Substantially Equivalent | Cmt Medical Technologies, Ltd. | accessdata.fda.gov |
Compare with other makers
- 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, Fluoroscopic, Image-Intensified
Updated September 22, 2016. 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.