Vieworks Co., Ltd.: FDA filings under this applicant name
FDA lists 21 510(k) clearances under the applicant name “Vieworks Co., Ltd.” (first 2007, latest 2026), across 4 product codes in 1 review panel. Median 510(k) review time under this name: 107 days. Since 2017 the median was 97 days, against 106 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 |
|---|---|---|
| 2012 | 1 | 122 |
| 2013 | 3 | 115 |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 3 | 149 |
| 2017 | 1 | 41 |
| 2018 | 1 | 29 |
| 2019 | 1 | 28 |
| 2020 | 1 | 27 |
| 2021 | 0 | — |
| 2022 | 2 | 142 |
| 2023 | 0 | — |
| 2024 | 1 | 206 |
| 2025 | 2 | 225 |
| 2026 | 2 | 128 |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Vieworks Co., Ltd. took a median 97 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 106 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| MQB | Solid State X-Ray Imager (Flat Panel/Digital Imager) | 14 | 14 |
| LLZ | System, Image Processing, Radiological | 4 | 4 |
| MUE | Full Field Digital, System, X-Ray, Mammographic | 2 | 2 |
| KPR | System, X-Ray, Stationary | 1 | 1 |
Review panels
- Radiology (21)
Most recent Vieworks Co., Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K260820 | VIVIX-S 4386W (FXRD-4386WA) | MQB | 2026-06-18 | 97 |
| K254092 | Bellalun 2D (VDMS-1000S) | MUE | 2026-05-28 | 160 |
| K251410 | VXvue | LLZ | 2025-11-04 | 181 |
| K241113 | VIVIX-M | MUE | 2025-01-16 | 269 |
| K241125 | VIVIX-S 1751S | MQB | 2024-11-15 | 206 |
| K220239 | Solid State X-ray Imager(Model: FXRD-4386WB) | MQB | 2022-09-13 | 228 |
| K221512 | Vivix-S FW (Model: FXRD-2530FAW, FXRD-3643FAW, FXRD-4343FAW) | MQB | 2022-07-20 | 57 |
| K200418 | VIVIX-S VW | MQB | 2020-03-18 | 27 |
| K190611 | VIVIX-S 1751S | MQB | 2019-04-08 | 28 |
| K181003 | VIVIX-S 1717V | MQB | 2018-05-15 | 29 |
11 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Vieworks 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 Vieworks Co., Ltd.?
FDA lists 21 510(k) clearances under the applicant name “Vieworks Co., Ltd.” (first 2007, latest 2026), across 4 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 Vieworks Co., Ltd.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Vieworks Co., Ltd. is 107 days. Since 2017: 97 days, versus 106 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Vieworks Co., Ltd.?
The most frequent FDA product codes under this applicant name are MQB (Solid State X-Ray Imager (Flat Panel/Digital Imager), 14); LLZ (System, Image Processing, Radiological, 4); MUE (Full Field Digital, System, X-Ray, Mammographic, 2).
Next steps
- See all 21 Vieworks Co., Ltd. clearances with predicates and recalls
- Run predicate analysis for product code MQB, Vieworks 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, 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.