Cleared Traditional

OEC One

K182626 · Ge Hualun Medical Systems Co. , Ltd. · Radiology

Nov 2018

Decision

53d

Days

Class 2

Risk

About This 510(k) Submission

K182626 is an FDA 510(k) clearance for the OEC One, a Image-intensified Fluoroscopic X-ray System, Mobile (Class II — Special Controls, product code OXO), submitted by Ge Hualun Medical Systems Co. , Ltd. (Beijing, CN). The FDA issued a Cleared decision on November 16, 2018, 53 days after receiving the submission on September 24, 2018. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1650.

Submission Details

510(k) Number	K182626 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 24, 2018
Decision Date	November 16, 2018
Days to Decision	53 days
Submission Type	Traditional
Review Panel	Radiology (RA)
Summary	Summary PDF

Device Classification

Product Code	OXO — Image-intensified Fluoroscopic X-ray System, Mobile
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 892.1650
Definition	Fluoroscopy Of The Human Body.