SecureFoam 25038
by Bionix, LLC
SecureFoam 25038 is a radiological whole-body positioner (FDA Class II; FDA product code IYE, Accelerator, linear, medical) made by Bionix, LLC, cleared under FDA 510(k) K040773 on 9 Apr 2004 and listed in FDA GUDID since 31 May 2024 (UDI-DI 00714646001245), 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 | GUDID listing | Number00714646001245 | Date31 May 2024 | StatusListed |
| United States | FDA 510(k)SESE | NumberK040773 | Date9 Apr 2004 | StatusActive |
Official records
- AccessGUDID record 00714646001245
- FDA 510(k) database K040773
Across registries
- FDA 510(k) K040773 decided 9 Apr 2004 Active
- FDA GUDID UDI-DI 00714646001245 listed 31 May 2024 Listed
Timeline
- Cleared FDA 510(k) K040773
- Listed FDA GUDID 00714646001245
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- SecureFoam
- Generic name
- Radiological whole-body positioner
- Model / Ref / Catalog
- 25038
- Primary DI / UDI-DI
- 00714646001245
- 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
- MRI safety
- MR Safe
Similar devices in this category
Other devices filed under Radiological whole-body positioner.