The following data is part of a premarket notification filed by Brainlab Ag with the FDA for Exactrac 3rd Party, Exactrac X-ray 6d 3rd Party, Exactrac Oem.
| Device ID | K072046 |
| 510k Number | K072046 |
| Device Name: | EXACTRAC 3RD PARTY, EXACTRAC X-RAY 6D 3RD PARTY, EXACTRAC OEM |
| Classification | Accelerator, Linear, Medical |
| Applicant | BRAINLAB AG KAPELLENSTRASSE 12 Feldkirchen, DE 85622 |
| Contact | Rainer Birkenbach |
| Correspondent | Rainer Birkenbach BRAINLAB AG KAPELLENSTRASSE 12 Feldkirchen, DE 85622 |
| Product Code | IYE |
| CFR Regulation Number | 892.5050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-07-25 |
| Decision Date | 2007-10-17 |
| Summary: | summary |