Cleared Traditional

VXvue

K251410 · Vieworks Co., Ltd. · Radiology
Nov 2025
Decision
181d
Days
Class 2
Risk

About This 510(k) Submission

K251410 is an FDA 510(k) clearance for the VXvue, a System, Image Processing, Radiological (Class II — Special Controls, product code LLZ), submitted by Vieworks Co., Ltd. (Anyang-Si, KR). The FDA issued a Cleared decision on November 4, 2025, 181 days after receiving the submission on May 7, 2025. This device falls under the Radiology review panel. Regulated under 21 CFR 892.2050.

Submission Details

510(k) Number K251410 FDA.gov
FDA Decision Cleared SESE
Date Received May 07, 2025
Decision Date November 04, 2025
Days to Decision 181 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF

Device Classification

Product Code LLZ — System, Image Processing, Radiological
Device Class Class II — Special Controls
CFR Regulation 21 CFR 892.2050