Medical Device Manufacturer · KR , Gyeonggi-Do

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

21 submissions · 21 cleared · Since 2007

Recent clearances: Bellalun 2D (VDMS-1000S), VXvue, VIVIX-M

Total

Cleared

Denied

Vieworks Co., Ltd. has 21 FDA 510(k) cleared radiology devices. Based in Gyeonggi-Do, KR.

Latest FDA clearance: Jun 2026. Active since 2007.

Browse the complete list of FDA 510(k) cleared radiology devices from this manufacturer. Filter by specialty or product code using the sidebar.

510(k) submissions have been managed by LK Consulting Group USA, Inc. as regulatory consultant.

Vieworks Co., Ltd. is one of 351 FDA 510(k) medical device manufacturers from South Korea in the dataset, ranked by real submission volume.

FDA 510(k) Regulatory Record - Vieworks Co., Ltd.

21 devices

1-12 of 21

Cleared Jun 18, 2026

VIVIX-S 4386W (FXRD-4386WA)

K260820 · MQB

Radiology · 97d

Cleared May 28, 2026

Bellalun 2D (VDMS-1000S)

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)

Data Source

Sourced from the FDA 510(k) public files . 175,450 total devices indexed.

Last updated: Jul 06, 2026

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

FDA 510(k) Regulatory Record - Vieworks Co., Ltd.

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