Cleared Traditional

K211780 - ZEN-2090 Turbo
(FDA 510(k) Clearance)

K211780 · Genoray Co., Ltd. · Radiology

Mar 2022

Decision

273d

Days

Class 2

Risk

K211780 is an FDA 510(k) clearance for the ZEN-2090 Turbo, a Interventional Fluoroscopic X-ray System (Class II — Special Controls, product code OWB), submitted by Genoray Co., Ltd. (Seongnam-Si, KR). The FDA issued a Cleared decision on March 9, 2022, 273 days after receiving the submission on June 9, 2021. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1650.

Submission Details

510(k) Number	K211780 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 09, 2021
Decision Date	March 09, 2022
Days to Decision	273 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