Vieworks Co., Ltd. FDA Approvals

0 new drug approvals and 7 device clearances on file. This applicant is not matched to a listed company.

Newest first

A new drug approval is an original application; a 510(k) is a device shown equivalent to one already sold.

Product	What it is	Route	Decided
VIVIX-S 4386W (FXRD-4386WA)510(k)Jun 18, 2026Radiology	Radiology	510(k)Substantially Equivalent (Special)	Jun 18, 2026
Bellalun 2D (VDMS-1000S)510(k)May 28, 2026Radiology	Radiology	510(k)Substantially Equivalent (Traditional)	May 28, 2026
VXvue510(k)Nov 4, 2025Radiology	Radiology	510(k)Substantially Equivalent (Traditional)	Nov 4, 2025
VIVIX-M510(k)Jan 16, 2025Radiology	Radiology	510(k)Substantially Equivalent (Traditional)	Jan 16, 2025
VIVIX-S 1751S510(k)Nov 15, 2024Radiology	Radiology	510(k)Substantially Equivalent (Traditional)	Nov 15, 2024
Solid State X-ray Imager(Model: FXRD-4386WB)510(k)Sep 13, 2022Radiology	Radiology	510(k)Substantially Equivalent (Traditional)	Sep 13, 2022
Vivix-S FW (Model: FXRD-2530FAW, FXRD-3643FAW, FXRD-4343FAW)510(k)Jul 20, 2022Radiology	Radiology	510(k)Substantially Equivalent (Traditional)	Jul 20, 2022