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

Cleared Jun 18, 2026

VIVIX-S 4386W (FXRD-4386WA)

K260820 · MQB

Radiology · 97d

Cleared May 28, 2026

Bellalun 2D (VDMS-1000S)

K254092 · MUE

Radiology · 160d

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