The following data is part of a premarket notification filed by Brainlab, Ag with the FDA for Brainscan Conformal Rt Module.
| Device ID | K971367 |
| 510k Number | K971367 |
| Device Name: | BRAINSCAN CONFORMAL RT MODULE |
| Classification | Accelerator, Linear, Medical |
| Applicant | BRAINLAB, AG AMMERTHALSTRASSE 8 Heimstetten, DE 85551 |
| Contact | Stefan Vilsmeier |
| Correspondent | Stefan Vilsmeier 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 | 1997-04-14 |
| Decision Date | 1997-10-27 |