The following data is part of a premarket notification filed by Brainlab Med. Computersysteme Gmbh with the FDA for Brainlab Linac Hardware.
| Device ID | K934657 |
| 510k Number | K934657 |
| Device Name: | BRAINLAB LINAC HARDWARE |
| Classification | Accelerator, Linear, Medical |
| Applicant | BRAINLAB MED. COMPUTERSYSTEME GMBH 120 DEFREEST SRIVE Troy, NY 12180 |
| Contact | Stefan Vilsmeier |
| Correspondent | Stefan Vilsmeier BRAINLAB MED. COMPUTERSYSTEME GMBH 120 DEFREEST SRIVE Troy, NY 12180 |
| Product Code | IYE |
| CFR Regulation Number | 892.5050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-09-21 |
| Decision Date | 1994-07-22 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04056481004279 | K934657 | 000 |
| 04056481004095 | K934657 | 000 |
| 04056481004125 | K934657 | 000 |
| 04056481004132 | K934657 | 000 |
| 04056481004149 | K934657 | 000 |
| 04056481004156 | K934657 | 000 |
| 04056481004163 | K934657 | 000 |
| 04056481004187 | K934657 | 000 |
| 04056481004194 | K934657 | 000 |
| 04056481004217 | K934657 | 000 |
| 04056481004224 | K934657 | 000 |
| 04056481004231 | K934657 | 000 |
| 04056481004255 | K934657 | 000 |
| 04056481004262 | K934657 | 000 |
| 04056481004088 | K934657 | 000 |