Oec 3D

Q: When was Oec 3D cleared by the FDA?

Oec 3D (K203346) received a 510(k) decision of Substantially Equivalent on March 5, 2021, 112 days after the submission was received.

Q: What is the product code of K203346?

The FDA product code is OXO – Image-Intensified Fluoroscopic X-Ray System, Mobile, a Class II (moderate risk) device regulated under 21 CFR 892.1650.

FDA 510(k) K203346 · Ge Oec Medical Systems, Inc.

Substantially Equivalent

510(k) numberK203346

Submission

Device name: Oec 3D
Applicant: Ge Oec Medical Systems, Inc.
Salt Lake City, UT, US
Received: November 13, 2020
Decision date: March 5, 2021
Decision: Substantially Equivalent (SESE)
Type: Traditional 510(k)
Summary: 510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code: OXO – Image-Intensified Fluoroscopic X-Ray System, Mobile
Device class: Class II (moderate risk)
Regulation: 21 CFR 892.1650
Specialty: Radiology

Fluoroscopy of the human body.

Other 510(k)s with product code OXO

510(k)	Device	Applicant	Decision
K253296	Digital C-ARM with 3DOXO · Traditional	Allengers Medical Systems Limited	06/05/2026SE
K252579	Orthoscan TAU MVP Mini C-Arm SystemOXO · Traditional	Ziehm-Orthoscan, Inc.	01/14/2026SE
K253269	OEC One CFDOXO · Traditional	Ge Hualun Medical Systems Co. , Ltd.	11/26/2025SE
K251004	Dual-Mode Mobile C-Arm (Geelin500A, Geelin500M)OXO · Traditional	Hefei Chimed Intelligent Machine Co., Ltd.	11/06/2025SE
K250587	Orthoscan TAU Mini C-ArmOXO · Special	Ziehm-Orthoscan, Inc.	07/02/2025SE
K243452	Orthoscan VERSA Mini C-ArmOXO · Traditional	Ziehm-Orthoscan, Inc.	01/14/2025SE
K240828	OEC One ASDOXO · Traditional	Ge Hualun Medical Systems Co. , Ltd.	12/27/2024SE
K233669	Oec 3DOXO · Traditional	Ge Oec Medical Systems, Inc.	03/28/2024SE
K213113	Orthoscan Tau Mini C-ArmOXO · Special	Orthoscan, Inc.	10/21/2021SE
K192819	OEC EliteOXO · Special	Ge Oec Medical Systems, Inc.	11/08/2019SE

More from Ge Oec Medical Systems, Inc.

510(k)	Device	Decision
K233669	Oec 3DOXO · Traditional	03/28/2024SE
K192819	OEC EliteOXO · Special	11/08/2019SE
K172550	OEC EliteOXO · Traditional	11/16/2017SE
K171565	OEC EliteOWB · Traditional	08/10/2017SE
K132027	Oec 9800 PlusOWB · Special	05/01/2014SE
K111551	Oec(R) 9800, Oec(R) 9800 PlusOWB · Traditional	10/04/2011SE
K073543	Oec 9900 EliteOWB · Traditional	05/02/2008SE
K061953	9900 Plus Mobile Fluoroscopy System with 3D and Navigation OptionsOWB · Traditional	08/15/2006SE
K052039	GE Oec AltitudeIZI · Abbreviated	08/11/2005SE
K051490	GE Oec Everview 7500OXO · Traditional	07/07/2005SE

Questions and answers

When was Oec 3D cleared by the FDA?

Oec 3D (K203346) received a 510(k) decision of Substantially Equivalent on March 5, 2021, 112 days after the submission was received.

What is the product code of K203346?

The FDA product code is OXO – Image-Intensified Fluoroscopic X-Ray System, Mobile, a Class II (moderate risk) device regulated under 21 CFR 892.1650.