Mesh Insert Side Opening, Short Version 11-218
by Aktina Corp.
Mesh Insert Side Opening, Short Version 11-218 is a radiological whole-body positioner (FDA Class II; FDA product code JAI, Couch, Radiation Therapy, Powered) 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 B365112180), 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 | NumberB365112180 | 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 B365112180 listed 24 Sep 2016 Listed
Timeline
- Cleared FDA 510(k) K993522
- Listed FDA GUDID B365112180
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Mesh Insert Side Opening, Short Version
- Generic name
- Radiological whole-body positioner
- Model / reference
- 11-218
- Primary DI / UDI-DI
- B365112180
- 510(k) Number
- FDA product code
- JAI
- GMDN term
- Radiological whole-body positioner
- Device class
- Class II
- Regulation number
- 892.5770
- GUDID distribution status
- In Commercial Distribution
Similar devices in this category
Other devices filed under Radiological whole-body positioner.