Cleared Traditional

RMF-2000

K220073 · DRTECH Corporation · Radiology
Jan 2023
Decision
381d
Days
Class 2
Risk

About This 510(k) Submission

K220073 is an FDA 510(k) clearance for the RMF-2000, a Full Field Digital, System, X-ray, Mammographic (Class II — Special Controls, product code MUE), submitted by DRTECH Corporation (Jungwon-Gu, Seongnam-Si, KR). The FDA issued a Cleared decision on January 26, 2023, 381 days after receiving the submission on January 10, 2022. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1715.

Submission Details

510(k) Number K220073 FDA.gov
FDA Decision Cleared SESE
Date Received January 10, 2022
Decision Date January 26, 2023
Days to Decision 381 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

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