DEXIS™ Software 11
DEXIS™ Software 11 (1.012.4475) is a Class II device made by Dexis LLC, cleared under FDA 510(k) K151941 on 7 Oct 2015 and listed in FDA GUDID since 12 Nov 2021 (UDI-DI EKAV101244750), 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 | NumberEKAV101244750 | Date12 Nov 2021 | StatusListed |
| United States | FDA 510(k)SESE | NumberK151941 | Date7 Oct 2015 | StatusActive |
Official records
- FDA 510(k) database K151941
Across registries
- FDA 510(k) K151941 decided 7 Oct 2015 Active
- FDA GUDID UDI-DI EKAV101244750 listed 12 Nov 2021 Listed
Timeline
- Cleared FDA 510(k) K151941
- Listed FDA GUDID EKAV101244750
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- DEXIS™ Software
- Generic name
- Radiology information system application software
- Model / Ref / Catalog
- 11, 1.012.4475
- Primary DI / UDI-DI
- EKAV101244750
- 510(k) Number
- FDA product code
- LLZ
- GMDN term
- Radiology information system application software
- Device class
- Class II
- Regulation number
- 892.2050
- GUDID distribution status
- In Commercial Distribution
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