AcuityDRe 1
AcuityDRe 1 is an indirect flat panel x-ray detector (FDA Class II; FDA product code MQB, Solid State X-Ray Imager (Flat Panel/Digital Imager)) made by Radmedix, LLC, cleared under FDA 510(k) K210919 on 30 Apr 2021 and listed in FDA GUDID since 24 May 2021 (UDI-DI 00810035220447), active 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 | Number00810035220447 | Date24 May 2021 | StatusListed |
| United States | FDA 510(k)SESE | NumberK210919 | Date30 Apr 2021 | StatusActive |
Official records
- AccessGUDID record 00810035220447
- FDA 510(k) database K210919
Across registries
- FDA 510(k) K210919 decided 30 Apr 2021 Active
- FDA GUDID UDI-DI 00810035220447 listed 24 May 2021 Listed
Timeline
- Cleared FDA 510(k) K210919
- Listed FDA GUDID 00810035220447
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- AcuityDRe
- Generic name
- Indirect flat panel x-ray detector
- Model / reference
- 1
- Primary DI / UDI-DI
- 00810035220447
- 510(k) Number
- FDA product code
- MQB
- GMDN term
- Indirect flat panel x-ray detector
- Device class
- Class II
- Regulation number
- 892.1680
- GUDID distribution status
- In Commercial Distribution
- Sterilisation method
- Liquid Chemical
Similar devices in this category
Other devices filed under Indirect flat panel x-ray detector.