Cleared Traditional

ZEN-2090 PRO, FLUOROSCOPIC X-RAY SYSTEM, MODEL ZEN-2090 PRO

K091918 · Genoray Co., Ltd. · Radiology

Oct 2009

Decision

99d

Days

Class 2

Risk

About This 510(k) Submission

K091918 is an FDA 510(k) clearance for the ZEN-2090 PRO, FLUOROSCOPIC X-RAY SYSTEM, MODEL ZEN-2090 PRO, a Interventional Fluoroscopic X-ray System (Class II — Special Controls, product code OWB), submitted by Genoray Co., Ltd. (Salt Lake City, US). The FDA issued a Cleared decision on October 7, 2009, 99 days after receiving the submission on June 30, 2009. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1650.

Submission Details

510(k) Number	K091918 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 30, 2009
Decision Date	October 07, 2009
Days to Decision	99 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