The following data is part of a premarket notification filed by Elekta Limited with the FDA for Xvi R5.0.
| Device ID | K131965 |
| 510k Number | K131965 |
| Device Name: | XVI R5.0 |
| Classification | Accelerator, Linear, Medical |
| Applicant | Elekta Limited LINAC HOUSE, FLEMING WAY Crawley, West Sussex, GB Rh10 9rr |
| Contact | Andrew Hedges |
| Correspondent | Andrew Hedges Elekta Limited LINAC HOUSE, FLEMING WAY Crawley, West Sussex, 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 | 2013-06-27 |
| Decision Date | 2013-09-25 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05060191071208 | K131965 | 000 |
| 05060191071093 | K131965 | 000 |
| 05060191071109 | K131965 | 000 |
| 05060191071116 | K131965 | 000 |
| 05060191071123 | K131965 | 000 |
| 05060191071130 | K131965 | 000 |
| 05060191071147 | K131965 | 000 |
| 05060191071154 | K131965 | 000 |
| 05060191071161 | K131965 | 000 |
| 05060191071178 | K131965 | 000 |
| 05060191071185 | K131965 | 000 |
| 05060191071192 | K131965 | 000 |
| 05060191071048 | K131965 | 000 |