Freedom 1
Freedom 1 (AP2-K) is a Class II device made by CDR Systems Inc, cleared under FDA 510(k) K122888 on 30 Apr 2013 and listed in FDA GUDID since 8 Aug 2023 (UDI-DI 00628341930499), 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 | Number00628341930499 | Date8 Aug 2023 | StatusListed |
| United States | FDA 510(k)SESE | NumberK122888 | Date30 Apr 2013 | StatusActive |
Official records
- AccessGUDID record 00628341930499
- FDA 510(k) database K122888
Across registries
- FDA 510(k) K122888 decided 30 Apr 2013 Active
- FDA GUDID UDI-DI 00628341930499 listed 8 Aug 2023 Listed
Timeline
- Cleared FDA 510(k) K122888
- Listed FDA GUDID 00628341930499
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Freedom
- Generic name
- Indexed-immobilization patient positioning system
- Model / Ref / Catalog
- 1, AP2-K
- Primary DI / UDI-DI
- 00628341930499
- 510(k) Number
- FDA product code
- IYE
- GMDN term
- Indexed-immobilization patient positioning system
- Device class
- Class II
- Regulation number
- 892.5050
- GUDID distribution status
- In Commercial Distribution
- MRI safety
- MR Conditional
Similar devices in this category
Other devices filed under Indexed-immobilization patient positioning system.