Cleared Traditional

RSM 1824C with RConsole1

K162670 · DRTECH Corporation · Radiology
Feb 2017
Decision
150d
Days
Class 2
Risk

About This 510(k) Submission

K162670 is an FDA 510(k) clearance for the RSM 1824C with RConsole1, a Full Field Digital, System, X-ray, Mammographic (Class II — Special Controls, product code MUE), submitted by DRTECH Corporation (Seongnam-Si, KR). The FDA issued a Cleared decision on February 23, 2017, 150 days after receiving the submission on September 26, 2016. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1715.

Submission Details

510(k) Number K162670 FDA.gov
FDA Decision Cleared SESE
Date Received September 26, 2016
Decision Date February 23, 2017
Days to Decision 150 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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