Cleared Special

TOPAZ Mobile DR System

K201124 · DRGEM Corporation · Radiology
May 2020
Decision
22d
Days
Class 2
Risk

About This 510(k) Submission

K201124 is an FDA 510(k) clearance for the TOPAZ Mobile DR System, a System, X-ray, Mobile (Class II — Special Controls, product code IZL), submitted by DRGEM Corporation (Gwangmyeong-Si, KR). The FDA issued a Cleared decision on May 19, 2020, 22 days after receiving the submission on April 27, 2020. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1720.

Submission Details

510(k) Number K201124 FDA.gov
FDA Decision Cleared SESE
Date Received April 27, 2020
Decision Date May 19, 2020
Days to Decision 22 days
Submission Type Special
Review Panel Radiology (RA)
Summary Summary PDF

Device Classification

Product Code IZL — System, X-ray, Mobile
Device Class Class II — Special Controls
CFR Regulation 21 CFR 892.1720

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