Cleared Special

OEC 9800 PLUS

K132027 · Ge Oec Medical Systems, Inc. · Radiology

May 2014

Decision

304d

Days

Class 2

Risk

About This 510(k) Submission

K132027 is an FDA 510(k) clearance for the OEC 9800 PLUS, a Interventional Fluoroscopic X-ray System (Class II — Special Controls, product code OWB), submitted by Ge Oec Medical Systems, Inc. (Salt Lake City, US). The FDA issued a Cleared decision on May 1, 2014, 304 days after receiving the submission on July 1, 2013. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1650.

Submission Details

510(k) Number	K132027 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 01, 2013
Decision Date	May 01, 2014
Days to Decision	304 days
Submission Type	Special
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