The following data is part of a premarket notification filed by Gmv Soluciones Globales Internet S.a.u. with the FDA for Radiance V2.
| Device ID | K133655 |
| 510k Number | K133655 |
| Device Name: | RADIANCE V2 |
| Classification | System, Planning, Radiation Therapy Treatment |
| Applicant | GMV SOLUCIONES GLOBALES INTERNET S.A.U. ASTERWEG 19 Amsterdam, Noord Holland, NL 1031 Hl |
| Contact | Albert Koster |
| Correspondent | Albert Koster GMV SOLUCIONES GLOBALES INTERNET S.A.U. ASTERWEG 19 Amsterdam, Noord Holland, NL 1031 Hl |
| Product Code | MUJ |
| CFR Regulation Number | 892.5050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-11-27 |
| Decision Date | 2014-01-31 |
| Summary: | summary |