The following data is part of a premarket notification filed by Brainlab Med. Computersysteme Gmbh with the FDA for Brainlab Micro Multi-leaf Collimator.
| Device ID | K970586 |
| 510k Number | K970586 |
| Device Name: | BRAINLAB MICRO MULTI-LEAF COLLIMATOR |
| Classification | Accelerator, Linear, Medical |
| Applicant | BRAINLAB MED. COMPUTERSYSTEME GMBH AMMERTHALSTRABE 8 85551 Heimstetten, DE |
| Contact | Stefan Vilsmeier |
| Correspondent | Stefan Vilsmeier BRAINLAB MED. COMPUTERSYSTEME GMBH AMMERTHALSTRABE 8 85551 Heimstetten, DE |
| Product Code | IYE |
| CFR Regulation Number | 892.5050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-02-14 |
| Decision Date | 1997-05-12 |