Cleared Traditional

VIVIX-M

K241113 · Vieworks Co., Ltd. · Radiology
Jan 2025
Decision
269d
Days
Class 2
Risk

About This 510(k) Submission

K241113 is an FDA 510(k) clearance for the VIVIX-M, a Full Field Digital, System, X-ray, Mammographic (Class II — Special Controls, product code MUE), submitted by Vieworks Co., Ltd. (Anyang-Si, KR). The FDA issued a Cleared decision on January 16, 2025, 269 days after receiving the submission on April 22, 2024. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1715.

Submission Details

510(k) Number K241113 FDA.gov
FDA Decision Cleared SESE
Date Received April 22, 2024
Decision Date January 16, 2025
Days to Decision 269 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF

Device Classification

Product Code MUE — Full Field Digital, System, X-ray, Mammographic
Device Class Class II — Special Controls
CFR Regulation 21 CFR 892.1715