Carbon Fiber Table Insert 11-206
by Aktina Corp.
Carbon Fiber Table Insert 11-206 is a radiological whole-body positioner (FDA Class II; FDA product code IYE, Accelerator, Linear, Medical) made by Aktina Corp., cleared under FDA 510(k) K993522 on 10 Jan 2000 and listed in FDA GUDID since 24 Sep 2016 (UDI-DI B365112060), active as of 23 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | NumberB365112060 | Date24 Sep 2016 | StatusListed |
| United States | FDA 510(k)SESE | NumberK993522 | Date10 Jan 2000 | StatusActive |
Official records
- FDA 510(k) database K993522
Across registries
- FDA 510(k) K993522 decided 10 Jan 2000 Active
- FDA GUDID UDI-DI B365112060 listed 24 Sep 2016 Listed
Timeline
- Cleared FDA 510(k) K993522
- Listed FDA GUDID B365112060
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Carbon Fiber Table Insert
- Generic name
- Radiological whole-body positioner
- Model / reference
- 11-206
- Primary DI / UDI-DI
- B365112060
- 510(k) Number
- FDA product code
- IYE
- GMDN term
- Radiological whole-body positioner
- Device class
- Class II
- Regulation number
- 892.5050
- GUDID distribution status
- In Commercial Distribution
Similar devices in this category
Other devices filed under Radiological whole-body positioner.