Cleared Traditional

PROMO

K251443 · DRGEM Corporation · Radiology
Aug 2025
Decision
105d
Days
Class 2
Risk

About This 510(k) Submission

K251443 is an FDA 510(k) clearance for the PROMO, 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 August 22, 2025, 105 days after receiving the submission on May 9, 2025. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1720.

Submission Details

510(k) Number K251443 FDA.gov
FDA Decision Cleared SESE
Date Received May 09, 2025
Decision Date August 22, 2025
Days to Decision 105 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

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