Medical Device Manufacturer · KR , Gyeonggi-Do

Vieworks Co., Ltd. - FDA 510(k) Cleared Devices

19 submissions · 19 cleared · Since 2007
19
Total
19
Cleared
0
Denied
FDA 510(k) Regulatory Record - Vieworks Co., Ltd. Radiology ✕
19 devices
1-19 of 19
Cleared Nov 04, 2025
VXvue
K251410 · LLZ
Radiology · 181d
Cleared Jan 16, 2025
VIVIX-M
K241113 · MUE
Radiology · 269d
Cleared Nov 15, 2024
VIVIX-S 1751S
K241125 · MQB
Radiology · 206d
Cleared Sep 13, 2022
Solid State X-ray Imager(Model: FXRD-4386WB)
K220239 · MQB
Radiology · 228d
Cleared Jul 20, 2022
Vivix-S FW (Model: FXRD-2530FAW, FXRD-3643FAW, FXRD-4343FAW)
K221512 · MQB
Radiology · 57d
Cleared Mar 18, 2020
VIVIX-S VW
K200418 · MQB
Radiology · 27d
Cleared Apr 08, 2019
VIVIX-S 1751S
K190611 · MQB
Radiology · 28d
Cleared May 15, 2018
VIVIX-S 1717V
K181003 · MQB
Radiology · 29d
Cleared Feb 08, 2017
VIVIX-S 1417N
K163703 · MQB
Radiology · 41d
Cleared Aug 05, 2016
QXLink
K161113 · LLZ
Radiology · 107d
Cleared Feb 26, 2016
VIVIX-S 1012N
K152855 · MQB
Radiology · 150d
Cleared Feb 26, 2016
VIVIX-S 1717N
K152894 · MQB
Radiology · 149d
Cleared Sep 12, 2013
QXLINK
K132302 · LLZ
Radiology · 50d
Cleared Feb 01, 2013
VIVIX-S WIRELESS
K122865 · MQB
Radiology · 136d
Cleared Jan 11, 2013
VIVIX-S WITH VXVUE
K122866 · MQB
Radiology · 115d
Cleared May 04, 2012
VIVIX-S
K120020 · MQB
Radiology · 122d
Cleared Jul 21, 2009
QXLINK
K092081 · LLZ
Radiology · 12d
Cleared Apr 16, 2008
DIGITAL RADIOGRAPHY SYSTEM, MODEL QXR-16
K080553 · KPR
Radiology · 48d
Cleared Nov 13, 2007
DIGITAL RADIOGRAPHY SYSTEM, MODEL: QXR-9
K073056 · MQB
Radiology · 14d
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