The AIO Solution 32015/9/2
The AIO Solution 32015/9/2 is a Class II device made by Orfit Industries NV, cleared under FDA 510(k) K191158 on 6 Aug 2019 and listed in FDA GUDID since 15 Apr 2026 (UDI-DI 05401172011514), 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 | Number05401172011514 | Date15 Apr 2026 | StatusListed |
| United States | FDA 510(k)SESE | NumberK191158 | Date6 Aug 2019 | StatusActive |
Official records
- AccessGUDID record 05401172011514
- FDA 510(k) database K191158
Across registries
- FDA 510(k) K191158 decided 6 Aug 2019 Active
- FDA GUDID UDI-DI 05401172011514 listed 15 Apr 2026 Listed
Timeline
- Cleared FDA 510(k) K191158
- Listed FDA GUDID 05401172011514
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- The AIO Solution
- Generic name
- Radiological whole-body positioner
- Model / reference
- 32015/9/2
- Primary DI / UDI-DI
- 05401172011514
- 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
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