Ewoosoft Co., Ltd.: FDA filings under this applicant name
FDA lists 31 510(k) clearances under the applicant name “Ewoosoft Co., Ltd.” (first 2013, latest 2025), across 2 product codes in 1 review panel. Median 510(k) review time under this name: 58 days. Since 2017 the median was 54 days, against 131 days for all cleared 510(k)s in the same product codes. 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 |
|---|---|---|
| 2013 | 3 | 87 |
| 2014 | 0 | — |
| 2015 | 1 | 74 |
| 2016 | 4 | 26 |
| 2017 | 3 | 27 |
| 2018 | 1 | 65 |
| 2019 | 2 | 32 |
| 2020 | 5 | 32 |
| 2021 | 4 | 95 |
| 2022 | 3 | 50 |
| 2023 | 3 | 58 |
| 2024 | 1 | 92 |
| 2025 | 1 | 141 |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Ewoosoft Co., Ltd. took a median 54 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 131 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| LLZ | System, Image Processing, Radiological | 29 | 29 |
| QIH | Automated Radiological Image Processing Software | 2 | 2 |
Review panels
- Radiology (31)
Most recent Ewoosoft Co., Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K250005 | Clever One | QIH | 2025-05-23 | 141 |
| K241114 | EzDent-i / E2 / Prora View / Smart M Viewer (v3.5) | LLZ | 2024-07-23 | 92 |
| K231757 | Ez3D-i /E3 | QIH | 2023-07-14 | 28 |
| K230468 | EzDent Web | LLZ | 2023-04-21 | 59 |
| K223820 | EzDent-i / E2 / Prora View/ Smart M Viewer | LLZ | 2023-02-17 | 58 |
| K222069 | Ez3D-i/E3 | LLZ | 2022-09-06 | 54 |
| K222145 | EzDent-i / E2 / Prora View/ Smart M Viewer | LLZ | 2022-08-12 | 23 |
| K220003 | EzOrtho v1.3 | LLZ | 2022-02-23 | 50 |
| K211795 | EzDent-i/ E2/ Prora View/ Smart M Viewer | LLZ | 2021-10-04 | 116 |
| K211700 | EzDent Web | LLZ | 2021-09-28 | 117 |
21 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Ewoosoft Co., Ltd..
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 Ewoosoft Co., Ltd.?
FDA lists 31 510(k) clearances under the applicant name “Ewoosoft Co., Ltd.” (first 2013, latest 2025), across 2 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 Ewoosoft Co., Ltd.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Ewoosoft Co., Ltd. is 58 days. Since 2017: 54 days, versus 131 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Ewoosoft Co., Ltd.?
The most frequent FDA product codes under this applicant name are LLZ (System, Image Processing, Radiological, 29); QIH (Automated Radiological Image Processing Software, 2).
Next steps
- See all 31 Ewoosoft Co., Ltd. clearances with predicates and recalls
- Run predicate analysis for product code LLZ, Ewoosoft Co., Ltd.'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.