K210500 is an FDA 510(k) clearance for the Elekta Synergy, Elekta Harmony, Elekta Infinity, Versa HD. This device is classified as a Accelerator, Linear, Medical (Class II - Special Controls, product code IYE).
Submitted by Elekta Limited (Crawley, GB). The FDA issued a Cleared decision on June 11, 2021, 109 days after receiving the submission on February 22, 2021.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.5050.
| 510(k) Number | K210500 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 22, 2021 |
| Decision Date | June 11, 2021 |
| Days to Decision | 109 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 |