K120520 is an FDA 510(k) clearance for the EXACTRAC ROBOTICS NOVALIS ROBOTICS. This device is classified as a Couch, Radiation Therapy, Powered (Class II - Special Controls, product code JAI).
Submitted by Brainlab AG (Feldkirchen, DE). The FDA issued a Cleared decision on June 29, 2012, 129 days after receiving the submission on February 21, 2012.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.5770.
| 510(k) Number | K120520 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 21, 2012 |
| Decision Date | June 29, 2012 |
| Days to Decision | 129 days |
| Submission Type | Traditional |
| Review Panel | Radiology (RA) |
| Summary | Summary PDF |
| Product Code | JAI — Couch, Radiation Therapy, Powered |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 892.5770 |