Cleared Traditional

K162670 - RSM 1824C with RConsole1

K162670 is an FDA 510(k) clearance for RSM 1824C with RConsole1, manufactured by DRTECH Corporation. The device is a Class 2 Radiology device with product code MUE cleared through the Traditional 510(k) pathway after a 150-day FDA review.

K162670 · DRTECH Corporation · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2017
Decision
150d
Days
Class 2
Risk

K162670 is an FDA 510(k) clearance for the RSM 1824C with RConsole1. Classified as Full Field Digital, System, X-ray, Mammographic (product code MUE), Class II - Special Controls.

Submitted by DRTECH Corporation (Seongnam-Si, KR). The FDA issued a Cleared decision on February 23, 2017 after a review of 150 days - an extended review cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1715 - the FDA radiology and imaging software oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Radiology review framework, consistent with the majority of Class II 510(k) submissions.

View all DRTECH Corporation devices

FDA 510(k) Submission Details - K162670

510(k) Number K162670 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
43d slower than avg
Panel avg: 107d · This submission: 150d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MUE Device Classification - Class 2, Special Controls

Product Code MUE Full Field Digital, System, X-ray, Mammographic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1715
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Radiology devices follow this clearance model.

Regulatory Peers - MUE Full Field Digital, System, X-ray, Mammographic

All 42
Devices cleared under the same product code (MUE) and FDA review panel - the closest regulatory comparables to K162670.
ASPIRE Cristalle
K173132 · Fujifilm Medical Systems U.S.A, Inc. · Oct 2017
Senographe Pristina
K163302 · Ge Healthcare · Sep 2017
RSM 2430C
K170930 · DRTECH Corporation · Apr 2017
Mammomat Fusion with Stereotactic Biopsy
K163252 · Siemens Medical Solutions USA, Inc. · Jan 2017
Senographe Pristina
K162268 · Ge Healthcare · Nov 2016
MAMMOMAT Fusion
K151645 · Siemens Medical Solutions USA, Inc. · Sep 2015