The following data is part of a premarket notification filed by Brainlab Ag with the FDA for M3 (mirco-multileaf Collimator.
| Device ID | K004022 |
| 510k Number | K004022 |
| Device Name: | M3 (MIRCO-MULTILEAF COLLIMATOR |
| 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 | 2000-12-27 |
| Decision Date | 2002-03-26 |