Cleared Special

OEC Elite MiniView

K171800 · Ge Hualun Medical Systems Co. , Ltd. · Radiology

Jul 2017

Decision

26d

Days

Class 2

Risk

About This 510(k) Submission

K171800 is an FDA 510(k) clearance for the OEC Elite MiniView, 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 July 12, 2017, 26 days after receiving the submission on June 16, 2017. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1650.

Submission Details

510(k) Number	K171800 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 16, 2017
Decision Date	July 12, 2017
Days to Decision	26 days
Submission Type	Special
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.