Cleared Traditional

EConsole2

K240243 · DRTECH Corporation · Radiology
Sep 2024
Decision
237d
Days
Class 2
Risk

About This 510(k) Submission

K240243 is an FDA 510(k) clearance for the EConsole2, 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 September 23, 2024, 237 days after receiving the submission on January 30, 2024. This device falls under the Radiology review panel. Regulated under 21 CFR 892.2050.

Submission Details

510(k) Number K240243 FDA.gov
FDA Decision Cleared SESE
Date Received January 30, 2024
Decision Date September 23, 2024
Days to Decision 237 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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