K003285 is an FDA 510(k) clearance for the EXAC TRAC 2.0 (NOVALIS BODY MODULE). This device is classified as a Accelerator, Linear, Medical (Class II - Special Controls, product code IYE).
Submitted by Brainlab AG (Heimstetten, DE). The FDA issued a Cleared decision on July 31, 2001, 285 days after receiving the submission on October 19, 2000.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.5050.
| 510(k) Number | K003285 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 19, 2000 |
| Decision Date | July 31, 2001 |
| Days to Decision | 285 days |
| Submission Type | Traditional |
| Review Panel | Radiology (RA) |
| Summary | Summary PDF |
| Product Code | IYE — Accelerator, Linear, Medical |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 892.5050 |