The following data is part of a premarket notification filed by Brainlab, Ag with the FDA for Exac Trac 2.0 (novalis Body Module).
| Device ID | K003285 |
| 510k Number | K003285 |
| Device Name: | EXAC TRAC 2.0 (NOVALIS BODY MODULE) |
| Classification | Accelerator, Linear, Medical |
| Applicant | BRAINLAB, AG AMMERTHALSTRASSE 8 Heimstetten, DE 85551 |
| Contact | Stefan Vilsmelier |
| Correspondent | Stefan Vilsmelier BRAINLAB, AG AMMERTHALSTRASSE 8 Heimstetten, DE 85551 |
| Product Code | IYE |
| CFR Regulation Number | 892.5050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-10-19 |
| Decision Date | 2001-07-31 |