Data / Medical devices / Spain / GMV Soluciones Global Internet SAU
GMV Soluciones Global Internet SAU: FDA-registered device maker in Tres Cantos Madrid(Province), Spain, 3 510(k) clearances
GMV Soluciones Global Internet SAU is registered with the FDA (registration 3009090417) in Tres Cantos Madrid(Province), Spain. It lists 1 device type. The FDA files 3 510(k) clearances under its listings, the newest dated May 17, 2024. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3009090417
- Address
- Isaac Newton 11, Tres Cantos Madrid(Province), Spain, 28760
- Owner or operator
- GMV Soluciones Global Internet SAU (10041328)
- Roles
- Manufacturer
- First device listed
- January 19, 2017
- Registered through
- 2026
- Brand names listed
- Radiance 5, Radiance V4, Radiance v3
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| System, Planning, Radiation Therapy Treatment | MUJ | 2 | Manufacturer | 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 |
|---|---|---|---|---|---|---|
| May 17, 2024 | K233236 | Radiance V5 | MUJ | Substantially Equivalent | Gmv Soluciones Globales Internet S.A.U. | accessdata.fda.gov |
| July 25, 2017 | K171885 | Radiance V4 | MUJ | Substantially Equivalent | Gmv Soluciones Globales Internet S.A.U. | accessdata.fda.gov |
| February 16, 2016 | K153368 | Radiance V3 | MUJ | Substantially Equivalent | Gmv Soluciones Globales Internet S.A.U. | accessdata.fda.gov |
Compare with other makers
Updated May 17, 2024. 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.