The following data is part of a premarket notification filed by New Radiant Technology S.p.a. with the FDA for Novac 11.
| Device ID | K112286 |
| 510k Number | K112286 |
| Device Name: | NOVAC 11 |
| Classification | Accelerator, Linear, Medical |
| Applicant | NEW RADIANT TECHNOLOGY S.P.A. 5 TIMBER LANE North Reading, MA 01864 |
| Contact | Maureen O'connel |
| Correspondent | Maureen O'connel NEW RADIANT TECHNOLOGY S.P.A. 5 TIMBER LANE North Reading, MA 01864 |
| Product Code | IYE |
| CFR Regulation Number | 892.5050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-08-09 |
| Decision Date | 2012-04-19 |
| Summary: | summary |