The following data is part of a premarket notification filed by Elekta Limited with the FDA for Elekta Unity.
| Device ID | K192482 |
| 510k Number | K192482 |
| Device Name: | Elekta Unity |
| Classification | Accelerator, Linear, Medical |
| Applicant | Elekta Limited Fleming Way Crawley, GB Rh10 9rr |
| Contact | Nicholas Power |
| Correspondent | Nicholas Power Elekta Limited 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 | 2019-09-10 |
| Decision Date | 2019-12-05 |