OEC Elite

FDA 510(k) K172550 · Ge Oec Medical Systems, Inc.

Substantially Equivalent

510(k) numberK172550

Submission

Device name
OEC Elite
Applicant
Ge Oec Medical Systems, Inc.
Salt Lake City, UT, US
Received
August 23, 2017
Decision date
November 16, 2017
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)DeviceApplicantDecision
K253296Digital C-ARM with 3DOXO · Traditional Allengers Medical Systems Limited06/05/2026SE
K252579Orthoscan TAU MVP Mini C-Arm SystemOXO · Traditional Ziehm-Orthoscan, Inc.01/14/2026SE
K253269OEC One CFDOXO · Traditional Ge Hualun Medical Systems Co. , Ltd.11/26/2025SE
K251004Dual-Mode Mobile C-Arm (Geelin500A, Geelin500M)OXO · Traditional Hefei Chimed Intelligent Machine Co., Ltd.11/06/2025SE
K250587Orthoscan TAU Mini C-ArmOXO · Special Ziehm-Orthoscan, Inc.07/02/2025SE
K243452Orthoscan VERSA Mini C-ArmOXO · Traditional Ziehm-Orthoscan, Inc.01/14/2025SE
K240828OEC One ASDOXO · Traditional Ge Hualun Medical Systems Co. , Ltd.12/27/2024SE
K233669Oec 3DOXO · Traditional Ge Oec Medical Systems, Inc.03/28/2024SE
K213113Orthoscan Tau Mini C-ArmOXO · Special Orthoscan, Inc.10/21/2021SE
K203346Oec 3DOXO · Traditional Ge Oec Medical Systems, Inc.03/05/2021SE

More from Ge Oec Medical Systems, Inc.

510(k)DeviceDecision
K233669Oec 3DOXO · Traditional 03/28/2024SE
K203346Oec 3DOXO · Traditional 03/05/2021SE
K192819OEC EliteOXO · Special 11/08/2019SE
K171565OEC EliteOWB · Traditional 08/10/2017SE
K132027Oec 9800 PlusOWB · Special 05/01/2014SE
K111551Oec(R) 9800, Oec(R) 9800 PlusOWB · Traditional 10/04/2011SE
K073543Oec 9900 EliteOWB · Traditional 05/02/2008SE
K0619539900 Plus Mobile Fluoroscopy System with 3D and Navigation OptionsOWB · Traditional 08/15/2006SE
K052039GE Oec AltitudeIZI · Abbreviated 08/11/2005SE
K051490GE Oec Everview 7500OXO · Traditional 07/07/2005SE

Questions and answers

When was OEC Elite cleared by the FDA?

OEC Elite (K172550) received a 510(k) decision of Substantially Equivalent on November 16, 2017, 85 days after the submission was received.

What is the product code of K172550?

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.