Cleared Special

OEC Elite

K192819 · Ge Oec Medical Systems, Inc. · Radiology

Nov 2019

Decision

38d

Days

Class 2

Risk

About This 510(k) Submission

K192819 is an FDA 510(k) clearance for the OEC Elite, a Image-intensified Fluoroscopic X-ray System, Mobile (Class II — Special Controls, product code OXO), submitted by Ge Oec Medical Systems, Inc. (Salt Lake City, US). The FDA issued a Cleared decision on November 8, 2019, 38 days after receiving the submission on October 1, 2019. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1650.

Submission Details

510(k) Number	K192819 FDA.gov
FDA Decision	Cleared SESE
Date Received	October 01, 2019
Decision Date	November 08, 2019
Days to Decision	38 days
Submission Type	Special
Review Panel	Radiology (RA)
Summary	Summary PDF

Device Classification

Product Code	OXO — Image-intensified Fluoroscopic X-ray System, Mobile
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 892.1650
Definition	Fluoroscopy Of The Human Body.