The following data is part of a premarket notification filed by Elekta Limited with the FDA for Synergy Platform, Synergy, Infinity, Versahd.
| Device ID | K192242 |
| 510k Number | K192242 |
| Device Name: | Synergy Platform, Synergy, Infinity, VersaHD |
| Classification | Accelerator, Linear, Medical |
| Applicant | Elekta Limited Linac House Fleming Way Crawley, GB Rh10 9rr |
| Contact | Irina Proutski |
| Correspondent | Irina Proutski Elekta Limited Linac House Fleming Way Crawley, GB Rh10 9rr |
| Product Code | IYE |
| CFR Regulation Number | 892.5050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-08-19 |
| Decision Date | 2019-11-22 |