Edda Technology, Inc.: FDA filings under this applicant name
FDA lists 5 510(k) clearances under 2 spellings of the applicant name “Edda Technology, Inc.” (first 2004, latest 2015), across 3 product codes in 1 review panel. Median 510(k) review time under this name: 123 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 1 | 62 |
| 2014 | 1 | 123 |
| 2015 | 1 | 177 |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| LLZ | System, Image Processing, Radiological | 3 | 3 |
| JAK | System, X-Ray, Tomography, Computed | 1 | 1 |
| OMJ | Chest X-Ray Computer Aided Detection | 1 | 1 |
Review panels
- Radiology (5)
Most recent Edda Technology, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K151414 | IQQA Guide | JAK | 2015-11-20 | 177 |
| K141745 | IQQA-BODYIMAGING SOFTWARE | LLZ | 2014-10-31 | 123 |
| K131498 | IQQA-LIVER MULTIMODALITY SOFTWARE | LLZ | 2013-07-25 | 62 |
| K061696 | IQQA-LIVER SOFTWARE | LLZ | 2006-11-13 | 152 |
| K042408 | IQQA-CHEST SOFTWARE PACKAGE | OMJ | 2004-10-08 | 35 |
Recalls
openFDA lists no recalls under a recalling firm named Edda Technology, Inc..
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
FDA spellings included
FDA records this applicant under 2 spellings (case, punctuation and legal-suffix variants of one name); this page adds them up. Filings per spelling:
- Edda Technology, Inc. (3)
- Edda Technology (2)
Frequently asked questions
How many FDA 510(k) clearances are listed under Edda Technology, Inc.?
FDA lists 5 510(k) clearances under 2 spellings of the applicant name “Edda Technology, Inc.” (first 2004, latest 2015), across 3 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Edda Technology, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Edda Technology, Inc. is 123 days.
Which FDA product codes appear under Edda Technology, Inc.?
The most frequent FDA product codes under this applicant name are LLZ (System, Image Processing, Radiological, 3); JAK (System, X-Ray, Tomography, Computed, 1); OMJ (Chest X-Ray Computer Aided Detection, 1).
Next steps
- See all 5 Edda Technology, Inc. clearances with predicates and recalls
- Run predicate analysis for product code LLZ, Edda Technology, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.