The following data is part of a premarket notification filed by Brainlab Ag with the FDA for Exactrac Gating.
| Device ID | K033287 |
| 510k Number | K033287 |
| Device Name: | EXACTRAC GATING |
| Classification | Accelerator, Linear, Medical |
| Applicant | BRAINLAB AG AMMERTHALSTRASSE 8 Heimstetten, DE 85551 |
| Contact | Rainer Birkenbach |
| Correspondent | Rainer Birkenbach 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 | 2003-10-14 |
| Decision Date | 2003-12-19 |
| Summary: | summary |