Predicate Research Report · generated 2026-08-21 · Print / save as PDF · Save to account
Vieworks Co., Ltd. — Predicate Candidate Screening
21 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
107 daysmedian FDA review time
206 days90th percentile
21clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K260820 | VIVIX-S 4386W (FXRD-4386WA) | Vieworks Co., Ltd. | 2026-06-18 | 97 | 0 |
| K254092 | Bellalun 2D (VDMS-1000S) | Vieworks Co., Ltd. | 2026-05-28 | 160 | 0 |
| K251410 | VXvue | Vieworks Co., Ltd. | 2025-11-04 | 181 | 0 |
| K241113 | VIVIX-M | Vieworks Co., Ltd. | 2025-01-16 | 269 | 0 |
| K241125 | VIVIX-S 1751S | Vieworks Co., Ltd. | 2024-11-15 | 206 | 0 |
| K220239 | Solid State X-ray Imager(Model: FXRD-4386WB) | Vieworks Co., Ltd. | 2022-09-13 | 228 | 0 |
| K221512 | Vivix-S FW (Model: FXRD-2530FAW, FXRD-3643FAW, FXRD-4343FAW) | Vieworks Co., Ltd. | 2022-07-20 | 57 | 0 |
| K200418 | VIVIX-S VW | Vieworks Co., Ltd. | 2020-03-18 | 27 | 0 |
| K190611 | VIVIX-S 1751S | Vieworks Co., Ltd. | 2019-04-08 | 28 | 0 |
| K181003 | VIVIX-S 1717V | Vieworks Co., Ltd. | 2018-05-15 | 29 | 0 |
| K163703 | VIVIX-S 1417N | Vieworks Co., Ltd. | 2017-02-08 | 41 | 0 |
| K161113 | QXLink | Vieworks Co., Ltd. | 2016-08-05 | 107 | 0 |
| K152894 | VIVIX-S 1717N | Vieworks Co., Ltd. | 2016-02-26 | 149 | 0 |
| K152855 | VIVIX-S 1012N | Vieworks Co., Ltd. | 2016-02-26 | 150 | 0 |
| K132302 | QXLINK | Vieworks Co., Ltd. | 2013-09-12 | 50 | 0 |
| K122865 | VIVIX-S WIRELESS | Vieworks Co., Ltd. | 2013-02-01 | 136 | 0 |
| K122866 | VIVIX-S WITH VXVUE | Vieworks Co., Ltd. | 2013-01-11 | 115 | 0 |
| K120020 | VIVIX-S | Vieworks Co., Ltd. | 2012-05-04 | 122 | 0 |
| K092081 | QXLINK | Vieworks Co., Ltd. | 2009-07-21 | 12 | 0 |
| K080553 | DIGITAL RADIOGRAPHY SYSTEM, MODEL QXR-16 | Vieworks Co., Ltd. | 2008-04-16 | 48 | 0 |
| K073056 | DIGITAL RADIOGRAPHY SYSTEM, MODEL: QXR-9 | Vieworks Co., Ltd. | 2007-11-13 | 14 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda