The following data is part of a premarket notification filed by Brainlab Med. Computersysteme Gmbh with the FDA for Brainlab Ct/x-ray Localizer.
| Device ID | K954861 |
| 510k Number | K954861 |
| Device Name: | BRAINLAB CT/X-RAY LOCALIZER |
| Classification | Accelerator, Linear, Medical |
| Applicant | BRAINLAB MED. COMPUTERSYSTEME GMBH GRUBER STRABE 46C 85586 Poing/munchen, DE 85586 |
| Contact | Michael Bertram |
| Correspondent | Michael Bertram BRAINLAB MED. COMPUTERSYSTEME GMBH GRUBER STRABE 46C 85586 Poing/munchen, DE 85586 |
| Product Code | IYE |
| CFR Regulation Number | 892.5050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-10-23 |
| Decision Date | 1996-08-05 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04056481004057 | K954861 | 000 |
| 04056481004040 | K954861 | 000 |