XVI R5.0
510(k) K131965
XVI R5.0 is a Class II device made by Elekta Limited, cleared under FDA 510(k) K131965 on 25 Sep 2013, active as of 22 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK131965 | Date25 Sep 2013 | StatusActive |
Official records
- FDA 510(k) database K131965
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- IYE
- Device class
- Class II
- Regulation
- 21 CFR Part 892.5050
- Advisory committee
- Radiology
- FDA decision
- SESE Substantially Equivalent
Devices cleared under K131965
Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.
| UDI-DI | Size and differences | |||
|---|---|---|---|---|
| XVI 1526749 | 1526749 | 05060191071048 | — | On the market |
| XVI 1526909 | 1526909 | 05060191071093 | — | On the market |
| XVI 1526910 | 1526910 | 05060191071109 | — | On the market |
| XVI 1526911 | 1526911 | 05060191071116 | — | On the market |
| XVI 1526914 | 1526914 | 05060191071123 | — | On the market |
| XVI 1526917 | 1526917 | 05060191071130 | — | On the market |
| XVI 1526918 | 1526918 | 05060191071147 | — | On the market |
| XVI 1526919 | 1526919 | 05060191071154 | — | On the market |
| XVI 1526924 | 1526924 | 05060191071161 | — | On the market |
| XVI 1526925 | 1526925 | 05060191071178 | — | On the market |
| XVI 1526926 | 1526926 | 05060191071185 | — | On the market |
| XVI 1526927 | 1526927 | 05060191071192 | — | On the market |
| XVI 1527278 | 1527278 | 05060191071208 | — | On the market |
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