EDDA TECHNOLOGY IQQA-Liver Multimodality
EDDA TECHNOLOGY IQQA-Liver Multimodality is a Class II device made by EDDA Technology, Inc., cleared under FDA 510(k) K131498 on 25 Jul 2013 and listed in FDA GUDID since 20 Sep 2016 (UDI-DI 00868466000213), 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 | Number00868466000213 | Date20 Sep 2016 | StatusListed |
| United States | FDA 510(k)SESE | NumberK131498 | Date25 Jul 2013 | StatusActive |
Official records
- AccessGUDID record 00868466000213
- FDA 510(k) database K131498
Across registries
- FDA 510(k) K131498 decided 25 Jul 2013 Active
- FDA GUDID UDI-DI 00868466000213 listed 20 Sep 2016 Listed
Timeline
- Cleared FDA 510(k) K131498
- Listed FDA GUDID 00868466000213
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Edda Technology
- Generic name
- Radiology DICOM image processing application software
- Model / reference
- IQQA-Liver Multimodality
- Primary DI / UDI-DI
- 00868466000213
- 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
Similar devices in this category
Other devices filed under Radiology DICOM image processing application software.
- Sim&Size V1.0.7 by SIM&CURE
- Veolity 1.7 by MeVis Medical Solutions AG
- BriefCase-Quantification (BC-QTF) by AIDOC MEDICAL LTD
- HipMap Femoroacetabular Impingement Analysis 3105001000 by Stryker Corp.
- 3mensio Workstation 10.7 by Pie Medical Imaging B.V.
- CAAS MR Solutions 5.3 by Pie Medical Imaging B.V.
- Advanced Visualization Workspace 881120 by Philips Medical Systems Nederland B.V.
- icobrain ctp 1 by icometrix NV
- RConsole1 1.0 by Drtech Corp.
- Quantra 2.2 R2LIC-2103-V2.2 by Hologic