Cleared Traditional

EConsole1

K231225 · DRTECH Corporation · Radiology
Oct 2023
Decision
173d
Days
Class 2
Risk

About This 510(k) Submission

K231225 is an FDA 510(k) clearance for the EConsole1, a System, Image Processing, Radiological (Class II — Special Controls, product code LLZ), submitted by DRTECH Corporation (Seongnam-Si, KR). The FDA issued a Cleared decision on October 18, 2023, 173 days after receiving the submission on April 28, 2023. This device falls under the Radiology review panel. Regulated under 21 CFR 892.2050.

Submission Details

510(k) Number K231225 FDA.gov
FDA Decision Cleared SESE
Date Received April 28, 2023
Decision Date October 18, 2023
Days to Decision 173 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF

Device Classification

Product Code LLZ — System, Image Processing, Radiological
Device Class Class II — Special Controls
CFR Regulation 21 CFR 892.2050

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