Data / Medical devices / United States / Edda Technology, Inc.
Edda Technology, Inc.: FDA-registered device maker in Princeton, NJ, United States, 5 510(k) clearances
Edda Technology, Inc. is registered with the FDA (registration 3004857110) in Princeton, NJ, United States. It lists 3 device types. The FDA files 5 510(k) clearances under its listings, the newest dated November 20, 2015. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3004857110
- Address
- 5 Independence Way Suite 210, Princeton, NJ, United States, 08540
- Owner or operator
- EDDA TECHNOLOGY, INC. (9066395)
- Roles
- Complaint file establishment, Manufacturer
- First device listed
- October 25, 2004
- Registered through
- 2027
- Brand names listed
- IQQA-BODYIMAGING, IQQA-Chest, IQQA-Guide, IQQA-LIVER SOFTWARE, IQQA-Liver Multimodality
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Chest X-Ray Computer Aided Detection | OMJ | 2 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| System, Image Processing, Radiological | LLZ | 2 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| System, X-Ray, Tomography, Computed | JAK | 2 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| November 20, 2015 | K151414 | IQQA Guide | JAK | Substantially Equivalent | Edda Technology | accessdata.fda.gov |
| October 31, 2014 | K141745 | IQQA-BODYIMAGING SOFTWARE | LLZ | Substantially Equivalent | Edda Technology | accessdata.fda.gov |
| July 25, 2013 | K131498 | IQQA-LIVER MULTIMODALITY SOFTWARE | LLZ | Substantially Equivalent | Edda Technology, Inc. | accessdata.fda.gov |
| November 13, 2006 | K061696 | IQQA-LIVER SOFTWARE | LLZ | Substantially Equivalent | Edda Technology, Inc. | accessdata.fda.gov |
| October 8, 2004 | K042408 | IQQA-CHEST SOFTWARE PACKAGE | OMJ | Substantially Equivalent | Edda Technology, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of System, Image Processing, Radiological
- All makers of System, X-Ray, Tomography, Computed
Updated November 20, 2015. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.