Data / Medical devices / South Korea / Vieworks Co., Ltd.
Vieworks Co., Ltd.: FDA-registered device maker in Hwaseong-si Gyeonggi, South Korea, 15 510(k) clearances
Vieworks Co., Ltd. is registered with the FDA (registration 3017585294) in Hwaseong-si Gyeonggi, South Korea. It lists 3 device types. The FDA files 15 510(k) clearances under its listings, the newest dated June 18, 2026. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3017585294
- Address
- 25-7, Jeongnamsandan 2-gil, Jeongnam-myeon, Hwaseong-si Gyeonggi, South Korea, 18514
- Owner or operator
- Vieworks Co., Ltd. (10024523)
- Roles
- Manufacturer
- First device listed
- January 19, 2013
- Registered through
- 2026
- Brand names listed
- Bellalun 2D, Carestream DRX-L Detector, Cuattro ONE, Cuattro ONE Long Format Digital Radiography, F3025-AW, FXRD-1417N, FXRD-1751SA, FXRD-1751SB and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Full Field Digital, System, X-Ray, Mammographic | MUE | 2 | Manufacturer | accessdata.fda.gov |
| Solid State X-Ray Imager (Flat Panel/Digital Imager) | MQB | 2 | Manufacturer | accessdata.fda.gov |
| System, Image Processing, Radiological | LLZ | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| June 18, 2026 | K260820 | VIVIX-S 4386W (FXRD-4386WA) | MQB | Substantially Equivalent | Vieworks Co., Ltd. | accessdata.fda.gov |
| May 28, 2026 | K254092 | Bellalun 2D (VDMS-1000S) | MUE | Substantially Equivalent | Vieworks Co., Ltd. | accessdata.fda.gov |
| November 4, 2025 | K251410 | VXvue | LLZ | Substantially Equivalent | Vieworks Co., Ltd. | accessdata.fda.gov |
| January 16, 2025 | K241113 | VIVIX-M | MUE | Substantially Equivalent | Vieworks Co., Ltd. | accessdata.fda.gov |
| November 15, 2024 | K241125 | VIVIX-S 1751S | MQB | Substantially Equivalent | Vieworks Co., Ltd. | accessdata.fda.gov |
| September 13, 2022 | K220239 | Solid State X-ray Imager(Model: FXRD-4386WB) | MQB | Substantially Equivalent | Vieworks Co., Ltd. | accessdata.fda.gov |
| July 20, 2022 | K221512 | Vivix-S FW (Model: FXRD-2530FAW, FXRD-3643FAW, FXRD-4343FAW) | MQB | Substantially Equivalent | Vieworks Co., Ltd. | accessdata.fda.gov |
| March 18, 2020 | K200418 | VIVIX-S VW | MQB | Substantially Equivalent | Vieworks Co., Ltd. | accessdata.fda.gov |
| May 15, 2018 | K181003 | VIVIX-S 1717V | MQB | Substantially Equivalent | Vieworks Co., Ltd. | accessdata.fda.gov |
| February 8, 2017 | K163703 | VIVIX-S 1417N | MQB | Substantially Equivalent | Vieworks Co., Ltd. | accessdata.fda.gov |
| August 5, 2016 | K161113 | QXLink | LLZ | Substantially Equivalent | Vieworks Co., Ltd. | accessdata.fda.gov |
| February 26, 2016 | K152894 | VIVIX-S 1717N | MQB | Substantially Equivalent | Vieworks Co., Ltd. | accessdata.fda.gov |
| February 26, 2016 | K152855 | VIVIX-S 1012N | MQB | Substantially Equivalent | Vieworks Co., Ltd. | accessdata.fda.gov |
| February 1, 2013 | K122865 | VIVIX-S WIRELESS | MQB | Substantially Equivalent | Vieworks Co., Ltd. | accessdata.fda.gov |
| January 11, 2013 | K122866 | VIVIX-S WITH VXVUE | MQB | Substantially Equivalent | Vieworks Co., Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Solid State X-Ray Imager (Flat Panel/Digital Imager)
- All makers of System, Image Processing, Radiological
- All makers of Full Field Digital, System, X-Ray, Mammographic
Updated June 18, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.