The following data is part of a premarket notification filed by Brainlab Ag with the FDA for Exactrac X-ray X-ray.
| Device ID | K120789 |
| 510k Number | K120789 |
| Device Name: | EXACTRAC X-RAY X-RAY |
| Classification | Accelerator, Linear, Medical |
| Applicant | BRAINLAB AG KAPELLENSTRASSE 12 Feldkirchen, DE 85622 |
| Contact | Alexander Schwiersch |
| Correspondent | Alexander Schwiersch 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 | 2012-03-15 |
| Decision Date | 2012-08-14 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04056481138400 | K120789 | 000 |
| 04056481006952 | K120789 | 000 |
| 04056481006945 | K120789 | 000 |
| 04056481004248 | K120789 | 000 |
| 04056481000264 | K120789 | 000 |