Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

1720753

FEI Number

1720753

Entity Name

GE OEC MEDICAL SYSTEMS, INC

City/State/Country

SALT LAKE CITY, UT, US

Establishment Address

384 N WRIGHT BROTHERS DR, SALT LAKE CITY, UT 84116, US

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

GE HealthCare Technologies Inc. (Owner Number: 9912004)

Owner / Operator Contact Address

3000 N. Grandview Blvd, Waukesha, WI 53188, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K122234

PMA Number

N/A

All Registered Proprietary Names

OEC 9800 OEC 3D OEC Elite OEC 9800 Plus OEC 9800 Plus OEC 3D OEC FluoroTrak 9800 Plus OEC 9800 Plus OEC 9900 Elite OEC Elite OEC 9900 Elite OEC Elite MiniView OEC Elite OEC 9800 OEC 9900 Elite

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
JAA	System, X-Ray, Fluoroscopic, Image-Intensified	Radiology	Class 2	892.1650	1992-10-16
OWB	Interventional Fluoroscopic X-Ray System	Radiology	Class 2	892.1650	1992-10-16
OXO	Image-Intensified Fluoroscopic X-Ray System, Mobile	Radiology	Class 2	892.1650	1992-10-16
OWB	Interventional Fluoroscopic X-Ray System	Radiology	Class 2	892.1650	2024-03-29
OXO	Image-Intensified Fluoroscopic X-Ray System, Mobile	Radiology	Class 2	892.1650	2024-03-29
JAA	System, X-Ray, Fluoroscopic, Image-Intensified	Radiology	Class 2	892.1650	2024-03-29
JAA	System, X-Ray, Fluoroscopic, Image-Intensified	Radiology	Class 2	892.1650	2020-01-10
OWB	Interventional Fluoroscopic X-Ray System	Radiology	Class 2	892.1650	2020-01-10
OXO	Image-Intensified Fluoroscopic X-Ray System, Mobile	Radiology	Class 2	892.1650	2020-01-10
OWB	Interventional Fluoroscopic X-Ray System	Radiology	Class 2	892.1650	1992-10-16
JAA	System, X-Ray, Fluoroscopic, Image-Intensified	Radiology	Class 2	892.1650	1992-10-16
OXO	Image-Intensified Fluoroscopic X-Ray System, Mobile	Radiology	Class 2	892.1650	1992-10-16
JAA	System, X-Ray, Fluoroscopic, Image-Intensified	Radiology	Class 2	892.1650	2014-08-01
OWB	Interventional Fluoroscopic X-Ray System	Radiology	Class 2	892.1650	2014-08-01
OXO	Image-Intensified Fluoroscopic X-Ray System, Mobile	Radiology	Class 2	892.1650	2014-08-01
JAA	System, X-Ray, Fluoroscopic, Image-Intensified	Radiology	Class 2	892.1650	2021-03-09
OXO	Image-Intensified Fluoroscopic X-Ray System, Mobile	Radiology	Class 2	892.1650	2021-03-09
OWB	Interventional Fluoroscopic X-Ray System	Radiology	Class 2	892.1650	2021-03-09
OXO	Image-Intensified Fluoroscopic X-Ray System, Mobile	Radiology	Class 2	892.1650	1992-10-16
OWB	Interventional Fluoroscopic X-Ray System	Radiology	Class 2	892.1650	1992-10-16
JAA	System, X-Ray, Fluoroscopic, Image-Intensified	Radiology	Class 2	892.1650	1992-10-16
OXO	Image-Intensified Fluoroscopic X-Ray System, Mobile	Radiology	Class 2	892.1650	2012-02-03
JAA	System, X-Ray, Fluoroscopic, Image-Intensified	Radiology	Class 2	892.1650	2012-02-03
OWB	Interventional Fluoroscopic X-Ray System	Radiology	Class 2	892.1650	2012-02-03
JAA	System, X-Ray, Fluoroscopic, Image-Intensified	Radiology	Class 2	892.1650	2008-09-25
OWB	Interventional Fluoroscopic X-Ray System	Radiology	Class 2	892.1650	2008-09-25
OXO	Image-Intensified Fluoroscopic X-Ray System, Mobile	Radiology	Class 2	892.1650	2008-09-25
OXO	Image-Intensified Fluoroscopic X-Ray System, Mobile	Radiology	Class 2	892.1650	2017-12-06
JAA	System, X-Ray, Fluoroscopic, Image-Intensified	Radiology	Class 2	892.1650	2017-12-06
OWB	Interventional Fluoroscopic X-Ray System	Radiology	Class 2	892.1650	2017-12-06
OXO	Image-Intensified Fluoroscopic X-Ray System, Mobile	Radiology	Class 2	892.1650	2009-09-03
OWB	Interventional Fluoroscopic X-Ray System	Radiology	Class 2	892.1650	2009-09-03
JAA	System, X-Ray, Fluoroscopic, Image-Intensified	Radiology	Class 2	892.1650	2009-09-03
JAA	System, X-Ray, Fluoroscopic, Image-Intensified	Radiology	Class 2	892.1650	2017-07-14
OXO	Image-Intensified Fluoroscopic X-Ray System, Mobile	Radiology	Class 2	892.1650	2017-07-14
OXO	Image-Intensified Fluoroscopic X-Ray System, Mobile	Radiology	Class 2	892.1650	2016-08-02
OXO	Image-Intensified Fluoroscopic X-Ray System, Mobile	Radiology	Class 2	892.1650	2017-08-11
OWB	Interventional Fluoroscopic X-Ray System	Radiology	Class 2	892.1650	2017-08-11
JAA	System, X-Ray, Fluoroscopic, Image-Intensified	Radiology	Class 2	892.1650	2017-08-11
OXO	Image-Intensified Fluoroscopic X-Ray System, Mobile	Radiology	Class 2	892.1650	1992-10-16
JAA	System, X-Ray, Fluoroscopic, Image-Intensified	Radiology	Class 2	892.1650	1992-10-16
OWB	Interventional Fluoroscopic X-Ray System	Radiology	Class 2	892.1650	1992-10-16
JAA	System, X-Ray, Fluoroscopic, Image-Intensified	Radiology	Class 2	892.1650	2012-09-25
OXO	Image-Intensified Fluoroscopic X-Ray System, Mobile	Radiology	Class 2	892.1650	2012-09-25
OWB	Interventional Fluoroscopic X-Ray System	Radiology	Class 2	892.1650	2012-09-25

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

GE HealthCare Technologies Inc.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3007120336	GE Healthcare Magyarorszag Kft.	Budapest, HU
3015060224	IMACTIS, SAS	SAINT MARTIN D'HERES, FR
2122726	GE MEDICAL SYSTEMS, LLC	Milwaukee, WI, US
9617766	GE BE PRIVATE LIMITED	WHITEFIELD, BANGALORE Karnataka, IN
9710090	GE ULTRASOUND KOREA, LTD.	Seongnam-Si Gyeonggi, KR

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K863853	Superior Medical Products	EAZY COVERS	1987-03-06
K953974	Medivision Medical Imaging, Ltd.	CAMVISION 1000	1996-09-09
K024012	Ge Oec Medical Systems	OEC 9800 E/CV+ DIGITAL MOBILE IMAGING SYSTEM	2003-03-20
K970608	Guidant Cardiac and Vascular Surgery	EVT MARKER BOARD	1997-04-21
K203010	Apelem-Dms Group	Platinum dRF Imaging System	2021-01-22

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0001-2007	GE OEC Medical Systems, Inc	2	GE 4 inch Anterior Cervical Post, GE Part Number 1006385 or 1006385-NAV, GE Healthcare OEC Medical Systems (an accessory used with the InstaTrak 3500 plus and 9800 C-Arm Navigation systems)
Z-0004-2010	Ge Healthcare	2	GE OEC 9900 Elite ESP To produce mobile fluoroscopic images of human anatomy.
Z-0005-2010	Ge Healthcare	2	GE OEC 9900 Elite GSP Fluoroscopes To produce mobile fluoroscopic images of human anatomy.
Z-0041-2007	GE OEC Medical Systems, Inc	2	GE OEC 9900 Elite Fluoroscopy System with Integrated Navigation,GE OEC Medical Systems Inc.
Z-0042-2007	GE OEC Medical Systems, Inc	2	OEC 9900 Elite Fluoroscopy System, Catalog No. 887208 and 887210, GE OEC Medical Systems, Inc.

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3033527282	Philips India Limited - Image Guided Therapy Systems Business Unit	Bengaluru Karnataka, IN
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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1720753. Last updated year: 2026. Please use registration number 1720753 when referencing this establishment in official correspondence.