CubeVue 3.6.0
CubeVue 3.6.0 is a Class II device made by CurveBeam LLC, cleared under FDA 510(k) K181962 on 7 Aug 2018 and listed in FDA GUDID since 10 Sep 2018 (UDI-DI 00863152000362), 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 | Number00863152000362 | Date10 Sep 2018 | StatusListed |
| United States | FDA 510(k)SESE | NumberK181962 | Date7 Aug 2018 | StatusActive |
Official records
- AccessGUDID record 00863152000362
- FDA 510(k) database K181962
Across registries
- FDA 510(k) K181962 decided 7 Aug 2018 Active
- FDA GUDID UDI-DI 00863152000362 listed 10 Sep 2018 Listed
Timeline
- Cleared FDA 510(k) K181962
- Listed FDA GUDID 00863152000362
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- CubeVue
- Generic name
- Radiology DICOM image processing application software
- Model / reference
- 3.6.0
- Primary DI / UDI-DI
- 00863152000362
- 510(k) Number
- FDA product code
- LLZ
- GMDN term
- Radiology DICOM image processing application software
- Device class
- Class II
- Regulation number
- 892.2050
- GUDID distribution status
- In Commercial Distribution
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