The following data is part of a premarket notification filed by Brainlab Ag with the FDA for Exactrac Robotics Novalis Robotics.
| Device ID | K120520 |
| 510k Number | K120520 |
| Device Name: | EXACTRAC ROBOTICS NOVALIS ROBOTICS |
| Classification | Couch, Radiation Therapy, Powered |
| Applicant | BRAINLAB AG KAPELLENSTRASSE 12 Feldkirchen, DE 85622 |
| Contact | Alexander Schwiersch |
| Correspondent | Alexander Schwiersch BRAINLAB AG KAPELLENSTRASSE 12 Feldkirchen, DE 85622 |
| Product Code | JAI |
| CFR Regulation Number | 892.5770 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-02-21 |
| Decision Date | 2012-06-29 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04056481006112 | K120520 | 000 |
| 04056481006105 | K120520 | 000 |