Cleared Traditional

OSCAR 15

K172180 · Genoray Co., Ltd. · Radiology

Feb 2018

Decision

205d

Days

Class 2

Risk

About This 510(k) Submission

K172180 is an FDA 510(k) clearance for the OSCAR 15, 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 February 9, 2018, 205 days after receiving the submission on July 19, 2017. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1650.

Submission Details

510(k) Number	K172180 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 19, 2017
Decision Date	February 09, 2018
Days to Decision	205 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