K131965 is an FDA 510(k) clearance for the XVI R5.0. This device is classified as a Accelerator, Linear, Medical (Class II - Special Controls, product code IYE).
Submitted by Elekta Limited (West Sussex, GB). The FDA issued a Cleared decision on September 25, 2013, 90 days after receiving the submission on June 27, 2013.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.5050.
| 510(k) Number | K131965 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 27, 2013 |
| Decision Date | September 25, 2013 |
| Days to Decision | 90 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 |