Medical Device Manufacturer · KR , Gyeonggi-Do

Vieworks Co., Ltd.

19 submissions · 19 cleared · Since 2007
19
Total
19
Cleared
0
Denied

Vieworks Co., Ltd. — FDA 510(k) Submissions

Vieworks Co., Ltd. has submitted 19 FDA 510(k) premarket notifications since 2007, of which 19 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Solid State X-ray Imager (flat Panel/digital Imager), System, Image Processing, Radiological, System, X-ray, Stationary, Full Field Digital, System, X-ray, Mammographic . Use the specialty filter in the sidebar to narrow results.

19 devices
1–19 of 19
VXvue
K251410 · LLZ System, Image Processing,... · Radiology
Nov 2025 181d
VIVIX-M
K241113 · MUE Full Field Digital,... · Radiology
Jan 2025 269d
VIVIX-S 1751S
K241125 · MQB Solid State X-ray Imager... · Radiology
Nov 2024 206d
Solid State X-ray Imager(Model: FXRD-4386WB)
K220239 · MQB Solid State X-ray Imager... · Radiology
Sep 2022 228d
Vivix-S FW (Model: FXRD-2530FAW, FXRD-3643FAW, FXRD-4343FAW)
K221512 · MQB Solid State X-ray Imager... · Radiology
Jul 2022 57d
VIVIX-S VW
K200418 · MQB Solid State X-ray Imager... · Radiology
Mar 2020 27d
VIVIX-S 1751S
K190611 · MQB Solid State X-ray Imager... · Radiology
Apr 2019 28d
VIVIX-S 1717V
K181003 · MQB Solid State X-ray Imager... · Radiology
May 2018 29d
VIVIX-S 1417N
K163703 · MQB Solid State X-ray Imager... · Radiology
Feb 2017 41d
QXLink
K161113 · LLZ System, Image Processing,... · Radiology
Aug 2016 107d
VIVIX-S 1012N
K152855 · MQB Solid State X-ray Imager... · Radiology
Feb 2016 150d
VIVIX-S 1717N
K152894 · MQB Solid State X-ray Imager... · Radiology
Feb 2016 149d
QXLINK
K132302 · LLZ System, Image Processing,... · Radiology
Sep 2013 50d
VIVIX-S WIRELESS
K122865 · MQB Solid State X-ray Imager... · Radiology
Feb 2013 136d
VIVIX-S WITH VXVUE
K122866 · MQB Solid State X-ray Imager... · Radiology
Jan 2013 115d
VIVIX-S
K120020 · MQB Solid State X-ray Imager... · Radiology
May 2012 122d
QXLINK
K092081 · LLZ System, Image Processing,... · Radiology
Jul 2009 12d
DIGITAL RADIOGRAPHY SYSTEM, MODEL QXR-16
K080553 · KPR System, X-ray, Stationary · Radiology
Apr 2008 48d
DIGITAL RADIOGRAPHY SYSTEM, MODEL: QXR-9
K073056 · MQB Solid State X-ray Imager... · Radiology
Nov 2007 14d
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