iFRAME Head Double P10107-391
iFRAME Head Double P10107-391 is a radiological whole-body positioner (FDA Class II; FDA product code IYE, Accelerator, Linear, Medical) made by IT-V Medizintechnik GmbH, cleared under FDA 510(k) K081218 on 21 Jul 2008 and listed in FDA GUDID since 1 Sep 2016 (UDI-DI 09120074393912), 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 | Number09120074393912 | Date1 Sep 2016 | StatusListed |
| United States | FDA 510(k)SESE | NumberK081218 | Date21 Jul 2008 | StatusActive |
Official records
- AccessGUDID record 09120074393912
- FDA 510(k) database K081218
Across registries
- FDA 510(k) K081218 decided 21 Jul 2008 Active
- FDA GUDID UDI-DI 09120074393912 listed 1 Sep 2016 Listed
Timeline
- Cleared FDA 510(k) K081218
- Listed FDA GUDID 09120074393912
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- iFRAME Head Double
- Generic name
- Radiological whole-body positioner
- Model / reference
- P10107-391
- Primary DI / UDI-DI
- 09120074393912
- 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.