The following data is part of a premarket notification filed by Gmv Soluciones Globales Internet S.a.u. with the FDA for Radiance V4.
| Device ID | K171885 |
| 510k Number | K171885 |
| Device Name: | Radiance V4 |
| Classification | System, Planning, Radiation Therapy Treatment |
| Applicant | GMV Soluciones Globales Internet S.A.U. Calle De Isaac Newton, 11 Tres Cantos, ES 28760 |
| Contact | Carlos Illana |
| Correspondent | Patsy Trisler Jd, Rac Qserve Group US Inc. 5600 Wisconsin Avenue Chevy Chase, MD 20815 |
| Product Code | MUJ |
| CFR Regulation Number | 892.5050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-06-26 |
| Decision Date | 2017-07-25 |
| Summary: | summary |