Cleared Traditional

JADE Mobile X-Ray

K183388 · DRGEM Corporation · Radiology
Feb 2019
Decision
61d
Days
Class 2
Risk

About This 510(k) Submission

K183388 is an FDA 510(k) clearance for the JADE Mobile X-Ray, 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 February 5, 2019, 61 days after receiving the submission on December 6, 2018. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1720.

Submission Details

510(k) Number K183388 FDA.gov
FDA Decision Cleared SESE
Date Received December 06, 2018
Decision Date February 05, 2019
Days to Decision 61 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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