The following data is part of a premarket notification filed by Brainlab Ag with the FDA for Novalis (shaped Beam Surgery System).
| Device ID | K002509 |
| 510k Number | K002509 |
| Device Name: | NOVALIS (SHAPED BEAM SURGERY SYSTEM) |
| Classification | System, Planning, Radiation Therapy Treatment |
| Applicant | BRAINLAB AG AMMERTHALSTRASSE 8 Heimstetten, DE 85551 |
| Contact | Stefan Vilsmeier |
| Correspondent | Stefan Vilsmeier BRAINLAB AG AMMERTHALSTRASSE 8 Heimstetten, DE 85551 |
| Product Code | MUJ |
| CFR Regulation Number | 892.5050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-08-15 |
| Decision Date | 2000-11-03 |