Cleared Traditional

Oscar 15 & Oscar 15i

K230787 · Genoray Co., Ltd. · Radiology

Jul 2023

Decision

120d

Days

Class 2

Risk

About This 510(k) Submission

K230787 is an FDA 510(k) clearance for the Oscar 15 & Oscar 15i, 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 July 20, 2023, 120 days after receiving the submission on March 22, 2023. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1650.

Submission Details

510(k) Number	K230787 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 22, 2023
Decision Date	July 20, 2023
Days to Decision	120 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