Cleared Traditional

OEC 3D

K233669 · Ge Oec Medical Systems, Inc. · Radiology

Mar 2024

Decision

134d

Days

Class 2

Risk

About This 510(k) Submission

K233669 is an FDA 510(k) clearance for the OEC 3D, 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 March 28, 2024, 134 days after receiving the submission on November 15, 2023. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1650.

Submission Details

510(k) Number	K233669 FDA.gov
FDA Decision	Cleared SESE
Date Received	November 15, 2023
Decision Date	March 28, 2024
Days to Decision	134 days
Submission Type	Traditional
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.