Cleared Traditional

TOPAZ Mobile X-ray System (Models : TOPAZ-32D, TOPAZ-40D)

K242015 · DRGEM Corporation · Radiology
Dec 2024
Decision
159d
Days
Class 2
Risk

About This 510(k) Submission

K242015 is an FDA 510(k) clearance for the TOPAZ Mobile X-ray System (Models : TOPAZ-32D, TOPAZ-40D), 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 December 16, 2024, 159 days after receiving the submission on July 10, 2024. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1720.

Submission Details

510(k) Number K242015 FDA.gov
FDA Decision Cleared SESE
Date Received July 10, 2024
Decision Date December 16, 2024
Days to Decision 159 days
Submission Type Traditional
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

Similar Devices — IZL System, X-ray, Mobile

All 233
Lux HD Detectors, DRX-LC Detector, DRX-Revolution Mobile X-Ray System
K253185 · Carestream Health · Mar 2026
AirRay-mini 80A, AirRay-mini 90A, AirRay-mini 80F, AirRay-mini 90F (AirRay-mini)
K253244 · Poskom Co., Ltd. · Feb 2026
Airbile-100
K250976 · Poskom Co., Ltd. · Dec 2025
Mobile X-ray unit (!M1)
K251710 · Solutions For Tomorrow AB · Oct 2025
BONX805
K243864 · Bontech Co., Ltd. · Sep 2025
PROMO
K251443 · DRGEM Corporation · Aug 2025