Cleared Traditional

2430MCA with Xmaru W

K202902 · Rayence Co., Ltd. · Radiology
Jun 2021
Decision
265d
Days
Class 2
Risk

About This 510(k) Submission

K202902 is an FDA 510(k) clearance for the 2430MCA 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 June 21, 2021, 265 days after receiving the submission on September 29, 2020. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1715.

Submission Details

510(k) Number K202902 FDA.gov
FDA Decision Cleared SESE
Date Received September 29, 2020
Decision Date June 21, 2021
Days to Decision 265 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