The following data is part of a premarket notification filed by Elekta Solutions Ab with the FDA for Elekta Unity.
| Device ID | K212114 |
| 510k Number | K212114 |
| Device Name: | Elekta Unity |
| Classification | Accelerator, Linear, Medical |
| Applicant | Elekta Solutions AB Kungstensgatan 18 Box 7593 Stockholm, SE Se10393 |
| Contact | Melinda Smith |
| Correspondent | Melinda Smith Elekta, Inc. 400 Perimeter Center Ter NE Suite 50 Atlanta, GA 30346 |
| Product Code | IYE |
| CFR Regulation Number | 892.5050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-07-07 |
| Decision Date | 2021-10-01 |