Cleared Special

2430TCA with Xmaru W

K243849 · Rayence Co., Ltd. · Radiology
Mar 2025
Decision
86d
Days
Class 2
Risk

About This 510(k) Submission

K243849 is an FDA 510(k) clearance for the 2430TCA with Xmaru W, a Full Field Digital, System, X-ray, Mammographic (Class II — Special Controls, product code MUE), submitted by Rayence Co., Ltd. (Hwaseong-Si, KR). The FDA issued a Cleared decision on March 12, 2025, 86 days after receiving the submission on December 16, 2024. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1715.

Submission Details

510(k) Number K243849 FDA.gov
FDA Decision Cleared SESE
Date Received December 16, 2024
Decision Date March 12, 2025
Days to Decision 86 days
Submission Type Special
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