Oec(R) 9800, Oec(R) 9800 Plus

Q: What is the product code of K111551?

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

FDA 510(k) K111551 · Ge Oec Medical Systems, Inc.

Substantially Equivalent

510(k) numberK111551

Submission

Device name: Oec(R) 9800, Oec(R) 9800 Plus
Applicant: Ge Oec Medical Systems, Inc.
Salt Lake City, UT, US
Received: June 3, 2011
Decision date: October 4, 2011
Decision: Substantially Equivalent (SESE)
Type: Traditional 510(k)
Summary: 510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code: OWB – Interventional Fluoroscopic X-Ray System
Device class: Class II (moderate risk)
Regulation: 21 CFR 892.1650
Specialty: Radiology

Interventional fluoroscopy

Other 510(k)s with product code OWB

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K253726	uAngio AVIVA CXOWB · Traditional	Shanghai United Imaging Healthcare Co., Ltd.	08/21/2026SE
K261413	Extron 3;EXTRON 6OWB · Traditional	DRTECH Corporation	08/19/2026SE
K254205	Zenition 30OWB · Traditional	Philips Medical Systems Nederland B.V.	08/07/2026SE
K260607	Shield System (Siemens 30x40)OWB · Special	Radiaction , Ltd.	07/31/2026SE
K253670	SmartCT (R3.0 (L10))OWB · Abbreviated	Philips Medical Systems B.V.	07/10/2026SE
K252735	C-beamOWB · Traditional	Pulmera, Inc.	05/22/2026SE
K252503	Intelligent NROWB · Traditional	Canon, Inc.	04/30/2026SE
K254173	ARTIS icono floor; ARTIS icono biplane; ARTIS icono ceiling; ARTIS phenoOWB · Traditional	Siemens Medical Solutions USA, Inc.	04/24/2026SE
K253752	ARTIS genio floor; ARTIS icono.explore floorOWB · Traditional	Siemens Medical Solutions USA, Inc.	04/23/2026SE
K252229	Belliger AceOWB · Traditional	Genoray Co., Ltd.	04/02/2026SE

More from Genoray Co., Ltd.

510(k)	Device	Decision
K233669	Oec 3DOXO · Traditional	03/28/2024SE
K203346	Oec 3DOXO · Traditional	03/05/2021SE
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
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(R) 9800, Oec(R) 9800 Plus cleared by the FDA?

Oec(R) 9800, Oec(R) 9800 Plus (K111551) received a 510(k) decision of Substantially Equivalent on October 4, 2011, 123 days after the submission was received.

What is the product code of K111551?

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