E-Woo Technology: FDA filings under this applicant name
FDA lists 8 510(k) clearances under the applicant name “E-Woo Technology” (first 2007, latest 2010), across 5 product codes in 1 review panel. Median 510(k) review time under this name: 84 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 | 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 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.
Frequently asked questions
How many FDA 510(k) clearances are listed under E-Woo Technology?
FDA lists 8 510(k) clearances under the applicant name “E-Woo Technology” (first 2007, latest 2010), across 5 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 E-Woo Technology?
The median time from FDA receipt to decision across 510(k)s cleared under the name E-Woo Technology is 84 days.
Which FDA product codes appear under E-Woo Technology?
The most frequent FDA product codes under this applicant name are JAK (System, X-Ray, Tomography, Computed, 3); OAS (X-Ray, Tomography, Computed, Dental, 2); EHD (Unit, X-Ray, Extraoral With Timer, 1).
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. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.