Cleared Traditional

ZEN-7000,SYSTEM,FLUROSCOPIC X-RAY SYSTEM

K140041 · Genoray Co., Ltd. · Radiology

Nov 2014

Decision

324d

Days

Class 2

Risk

About This 510(k) Submission

K140041 is an FDA 510(k) clearance for the ZEN-7000,SYSTEM,FLUROSCOPIC X-RAY SYSTEM, a Interventional Fluoroscopic X-ray System (Class II — Special Controls, product code OWB), submitted by Genoray Co., Ltd. (Tustin, US). The FDA issued a Cleared decision on November 28, 2014, 324 days after receiving the submission on January 8, 2014. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1650.

Submission Details

510(k) Number	K140041 FDA.gov
FDA Decision	Cleared SESE
Date Received	January 08, 2014
Decision Date	November 28, 2014
Days to Decision	324 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