The following data is part of a premarket notification filed by Elekta Limited with the FDA for Elekta Synergy, Elekta Harmony, Elekta Infinity, Versa Hd.
| Device ID | K210500 |
| 510k Number | K210500 |
| Device Name: | Elekta Synergy, Elekta Harmony, Elekta Infinity, Versa HD |
| Classification | Accelerator, Linear, Medical |
| Applicant | Elekta Limited Linac House, Fleming Way Crawley, GB Rh10 9rr |
| Contact | Lorenzo Muratori |
| Correspondent | Lorenzo Muratori Elekta, Inc. Linac House, Fleming Way, Crawley, West Sussex,RH10 9RR GB |
| Product Code | IYE |
| CFR Regulation Number | 892.5050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-02-22 |
| Decision Date | 2021-06-11 |