Dexis Software
by Dexis LLC
510(k) K090431
Dexis Software 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 EKAV101034090), 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 GUDID | NumberEKAV101034090 | Date14 Apr 2017 | StatusListed |
| United States | FDA 510(k)SESE 510(k) | 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 EKAV101034090 listed 14 Apr 2017 Listed
Timeline
- Cleared FDA 510(k) K090431
- Listed FDA GUDID EKAV101034090
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Generic name
- Radiology information system application software
- Model / Ref / Catalog
- 9, PLU235
- FDA applicant
- Dexis, LLC
- Primary DI / UDI-DI
- EKAV101034090
- 510(k) Number
- FDA product code
- LLZ
- GMDN term
- Radiology information system application software
- Device class
- Class II
- Regulation
- 21 CFR Part 892.2050
- Advisory committee
- Radiology
- FDA decision
- SESE Substantially Equivalent
- GUDID distribution status
- In Commercial Distribution
Devices cleared under K090431
Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.
| UDI-DI | Size and differences | |||
|---|---|---|---|---|
| DEXIS 10 (DEXIS Imaging Suite) | 1.008.7934 / 10 | EKAV100879340 | On the market | |
| DEXIS 10 (DEXIS Imaging Suite) 1.008.7934 | 1.008.7934 | D090100879340 | On the market | |
| DEXIS™ Software 9 | PLU235 / 9 | EKAV101034090 | On the market | |
| DEXIS™ Software 9 | PLU236 / 9 | EKAV101034080 | On the market | |
| DEXIS™ Software 9 | PLU238 / 9 | EKAV101034120 | On the market | |
| DEXIS™ Software 9 | PLU349 / 9 | EKAV101034110 | On the market |
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