DEXIS™ Software 11
DEXIS™ Software 11 (10124479) 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 19 Dec 2016 (UDI-DI EKAV101135330), 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 | NumberEKAV101135330 | Date19 Dec 2016 | 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 EKAV101135330 listed 19 Dec 2016 Listed
Timeline
- Cleared FDA 510(k) K151941
- Listed FDA GUDID EKAV101135330
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- Withdrawn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, 10124479
- Primary DI / UDI-DI
- EKAV101135330
- 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
Similar devices
Other devices filed under FDA product code LLZ (System, image processing, radiological).
- MEDIS 2MP2 QUAD-HEAD MEDICAL DIAGNOSTIC DISPLAY SYSTEM by Barco NV Display Systems
- SYNAPSE 3D LUNG AND ABDOMEN ANALYSIS by Fujifilm Medical System U.S.A., Inc.
- SmartTarget by Smarttarget, Ltd.
- SYNGO MBF by SIEMENS MEDICAL SOLUTIONS USA, INC.
- KODAK DIGITAL SCIENCE MEDICAL MODALITY ACQUISITION UNIT by Kodak Health Imaging Systems, Inc.
- CENTRICITY PACS SYSTEM by GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.
- 21.3 INCH MONOCHROME DIGITAL MAMMOGRAPHY LCD MONITOR MS55I2 (ML21055, MD211G5) by JVCKENWOOD Corporation
- CT42 CARDIAC COMPUTED TOMOGRAPHY (CT) SOFTWARE by Circle Cardiovascular Imaging Inc
- nCommand Lite System by Ionic Health
- M'ATH STD by Intelligence IN Medical Technologies