The following data is part of a premarket notification filed by Elekta Ltd. with the FDA for Xvi R4.5.
| Device ID | K100115 |
| 510k Number | K100115 |
| Device Name: | XVI R4.5 |
| Classification | Accelerator, Linear, Medical |
| Applicant | ELEKTA LTD. FLEMING WAY Crawley, GB Rh10 9rr |
| Contact | Andrew Hedges |
| Correspondent | Andrew Hedges ELEKTA LTD. 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 | 2010-01-15 |
| Decision Date | 2010-03-10 |
| Summary: | summary |