REGIUS Plate ED7W
REGIUS Plate ED7W is a Class II device made by Konica Minolta, Inc., cleared under FDA 510(k) K092717 on 30 Oct 2009 and listed in FDA GUDID since 19 Sep 2016 (UDI-DI 04560141931077), 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 | Number04560141931077 | Date19 Sep 2016 | StatusListed |
| United States | FDA 510(k)SESE | NumberK092717 | Date30 Oct 2009 | StatusActive |
Official records
- AccessGUDID record 04560141931077
- FDA 510(k) database K092717
Across registries
- FDA 510(k) K092717 decided 30 Oct 2009 Active
- FDA GUDID UDI-DI 04560141931077 listed 19 Sep 2016 Listed
Timeline
- Cleared FDA 510(k) K092717
- Listed FDA GUDID 04560141931077
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- REGIUS Plate
- Generic name
- Digital imaging storage phosphor screen
- Model / reference
- ED7W
- Primary DI / UDI-DI
- 04560141931077
- 510(k) Number
- FDA product code
- MQB
- GMDN term
- Digital imaging storage phosphor screen
- Device class
- Class II
- Regulation number
- 892.1680
- GUDID distribution status
- In Commercial Distribution
- MRI safety
- MR Unsafe
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