Cleared Traditional

OEC One

K172700 · Ge Hualun Medical Systems Co. , Ltd. · Radiology

Nov 2017

Decision

63d

Days

Class 2

Risk

About This 510(k) Submission

K172700 is an FDA 510(k) clearance for the OEC One, a Interventional Fluoroscopic X-ray System (Class II — Special Controls, product code OWB), submitted by Ge Hualun Medical Systems Co. , Ltd. (Beijing, CN). The FDA issued a Cleared decision on November 9, 2017, 63 days after receiving the submission on September 7, 2017. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1650.

Submission Details

510(k) Number	K172700 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 07, 2017
Decision Date	November 09, 2017
Days to Decision	63 days
Submission Type	Traditional
Review Panel	Radiology (RA)
Summary	Summary PDF

Device Classification

Product Code	OWB — Interventional Fluoroscopic X-ray System
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 892.1650
Definition	Interventional Fluoroscopy