Regius Model SIGMA2 A5ET
Regius Model SIGMA2 A5ET is a Class II device made by Konica Minolta, Inc., cleared under FDA 510(k) K120131 on 10 Feb 2012 and listed in FDA GUDID since 19 Sep 2016 (UDI-DI 04560141936393), 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 | Number04560141936393 | Date19 Sep 2016 | StatusListed |
| United States | FDA 510(k)SESE | NumberK120131 | Date10 Feb 2012 | StatusActive |
Official records
- AccessGUDID record 04560141936393
- FDA 510(k) database K120131
Across registries
- FDA 510(k) K120131 decided 10 Feb 2012 Active
- FDA GUDID UDI-DI 04560141936393 listed 19 Sep 2016 Listed
Timeline
- Cleared FDA 510(k) K120131
- Listed FDA GUDID 04560141936393
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Regius Model SIGMA2
- Generic name
- Computed radiography digital imaging scanner
- Model / reference
- A5ET
- Primary DI / UDI-DI
- 04560141936393
- 510(k) Number
- FDA product code
- MQB
- GMDN term
- Computed radiography digital imaging scanner
- Device class
- Class II
- Regulation number
- 892.1680
- GUDID distribution status
- In Commercial Distribution
- MRI safety
- MR Unsafe
Similar devices in this category
Other devices filed under Computed radiography digital imaging scanner.