K002509 is an FDA 510(k) clearance for the NOVALIS (SHAPED BEAM SURGERY SYSTEM). This device is classified as a System, Planning, Radiation Therapy Treatment (Class II - Special Controls, product code MUJ).
Submitted by Brainlab AG (Heimstetten, DE). The FDA issued a Cleared decision on November 3, 2000, 80 days after receiving the submission on August 15, 2000.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.5050.
| 510(k) Number | K002509 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 15, 2000 |
| Decision Date | November 03, 2000 |
| Days to Decision | 80 days |
| Submission Type | Traditional |
| Review Panel | Radiology (RA) |
| Summary | Summary PDF |
| Product Code | MUJ — System, Planning, Radiation Therapy Treatment |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 892.5050 |