E-Woo Technology: FDA clearances and approvals
E-Woo Technology has 8 FDA 510(k) clearances (first 2007, latest 2010), across 5 product codes in 1 review panel. Median 510(k) review time: 84 days.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 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 |
|---|---|---|---|
| JAK | System, X-Ray, Tomography, Computed | 3 | 3 |
| OAS | X-Ray, Tomography, Computed, Dental | 2 | 2 |
| EHD | Unit, X-Ray, Extraoral With Timer | 1 | 1 |
| MQB | Solid State X-Ray Imager (Flat Panel/Digital Imager) | 1 | 1 |
| MUH | System, X-Ray, Extraoral Source, Digital | 1 | 1 |
Review panels
- Radiology (8)
Most recent E-Woo Technology 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K091090 | DIGITAL FLAT PANEL X-RAY DETECTOR, MODEL XMARU 1717 | MQB | 2010-08-09 | 480 |
| K090526 | MEDICAL IMAGE PROCESSING UNIT, MODEL EZSENSOR | MUH | 2009-12-02 | 279 |
| K090991 | COMPUTED TOMOGRAPHY X-RAY SYSTEM, MODEL PICASSO-DUO | JAK | 2009-10-09 | 185 |
| K090171 | COMPUTED TOMOGRAPHY X-RAY SYSTEM, PAX-REVE3D | OAS | 2009-04-30 | 97 |
| K082410 | MASTER3DS | OAS | 2008-10-31 | 71 |
| K081899 | ANYRAY PORTABLE X-RAY SYSTEM | EHD | 2008-08-21 | 49 |
| K081847 | PICASSO MASTER, ECT AND MASTER 3D | JAK | 2008-08-21 | 52 |
| K070658 | DENTAL DIGITAL PANORAMIC/3D IMAGING SYSTEM | JAK | 2007-04-05 | 27 |
Recalls
openFDA lists no recalls under a recalling firm named E-Woo Technology.
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does E-Woo Technology have?
E-Woo Technology has 8 FDA 510(k) clearances (first 2007, latest 2010), across 5 product codes in 1 review panel.
How long does FDA take to clear E-Woo Technology's 510(k)s?
The median time from FDA receipt to decision across E-Woo Technology's cleared 510(k)s is 84 days.
What devices does E-Woo Technology make?
Its most frequent FDA product codes are JAK (System, X-Ray, Tomography, Computed, 3); OAS (X-Ray, Tomography, Computed, Dental, 2); EHD (Unit, X-Ray, Extraoral With Timer, 1).
Has E-Woo Technology had device recalls?
openFDA lists no recalls under a recalling firm name matching E-Woo Technology. Related entities may recall under other names.
Next steps
- See all 8 E-Woo Technology clearances with predicates and recalls
- Run predicate analysis for product code JAK, E-Woo Technology's most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.