DEXIS™ Software 9
DEXIS™ Software 9 (PLU236) is a Class II device made by Dexis LLC, cleared under FDA 510(k) K090431 on 22 Jun 2009 and listed in FDA GUDID since 14 Apr 2017 (UDI-DI EKAV101034080), 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 | NumberEKAV101034080 | Date14 Apr 2017 | StatusListed |
| United States | FDA 510(k)SESE | NumberK090431 | Date22 Jun 2009 | StatusActive |
Official records
- FDA 510(k) database K090431
Across registries
- FDA 510(k) K090431 decided 22 Jun 2009 Active
- FDA GUDID UDI-DI EKAV101034080 listed 14 Apr 2017 Listed
Timeline
- Cleared FDA 510(k) K090431
- Listed FDA GUDID EKAV101034080
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- Withdrawn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
- 9, PLU236
- Primary DI / UDI-DI
- EKAV101034080
- 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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