The following data is part of a premarket notification filed by Gmv Soluciones Globales Internet S.a.u. with the FDA for Radiance V3.
| Device ID | K153368 |
| 510k Number | K153368 |
| Device Name: | Radiance V3 |
| Classification | System, Planning, Radiation Therapy Treatment |
| Applicant | GMV SOLUCIONES GLOBALES INTERNET S.A.U. CALLE DE ISAAC NEWTON, 11 Madrid, ES 28760 |
| Contact | Carlos Illana |
| Correspondent | Patsy Trisler QSERVE GROUP US INC. PO BOX 940 Charlestown, NH 03603 |
| Product Code | MUJ |
| CFR Regulation Number | 892.5050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-11-23 |
| Decision Date | 2016-02-16 |
| Summary: | summary |