Cleared Traditional

OSCAR (OSCAR Prime, OSCAR Classic)

K181943 · Genoray Co., Ltd. · Radiology

Aug 2018

Decision

28d

Days

Class 2

Risk

About This 510(k) Submission

K181943 is an FDA 510(k) clearance for the OSCAR (OSCAR Prime, OSCAR Classic), 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 August 17, 2018, 28 days after receiving the submission on July 20, 2018. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1650.

Submission Details

510(k) Number	K181943 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 20, 2018
Decision Date	August 17, 2018
Days to Decision	28 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