The following data is part of a premarket notification filed by Brainlab Ag with the FDA for Frameless Radiosurgery Components.
| Device ID | K053500 |
| 510k Number | K053500 |
| Device Name: | FRAMELESS RADIOSURGERY COMPONENTS |
| Classification | Accelerator, Linear, Medical |
| Applicant | BRAINLAB AG AMMERTHALSTRASSE 8 Heimstetten, DE 85551 |
| Contact | Rainer Birkenbach |
| Correspondent | Rainer Birkenbach 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 | 2005-12-16 |
| Decision Date | 2006-02-03 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04056481002589 | K053500 | 000 |