Stage 2.3
Stage 2.3 (REF 200008) is a Class II device made by Spintech, Inc., cleared under FDA 510(k) K223079 on 28 Oct 2022 and listed in FDA GUDID since 27 Mar 2025 (UDI-DI 00866463000465), active (FDA 510(k)), not in commercial distribution (GUDID) 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 | Number00866463000465 | Date27 Mar 2025 | StatusListed |
| United States | FDA 510(k)SESE | NumberK223079 | Date28 Oct 2022 | StatusActive |
Official records
- AccessGUDID record 00866463000465
- FDA 510(k) database K223079
Across registries
- FDA 510(k) K223079 decided 28 Oct 2022 Active
- FDA GUDID UDI-DI 00866463000465 listed 27 Mar 2025 Listed
Timeline
- Cleared FDA 510(k) K223079
- Listed FDA GUDID 00866463000465
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Stage
- Generic name
- MRI system application software
- Model / Ref / Catalog
- 2.3, REF 200008
- Primary DI / UDI-DI
- 00866463000465
- 510(k) Number
- FDA product code
- LLZ, LNH
- GMDN term
- MRI system application software
- Device class
- Class II
- Regulation number
- 892.2050, 892.1000
- GUDID distribution status
- Not in Commercial Distribution
Similar devices in this category
Other devices filed under MRI system application software.