Accent 16, Accent 22

Q: What is the product code of K980322?

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) K980322 · GE Medical Systems

Substantially Equivalent

510(k) numberK980322

Submission

Device name: Accent 16, Accent 22
Applicant: GE Medical Systems
Waukesha, WI, US
Received: January 27, 1998
Decision date: April 24, 1998
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
K203346	Oec 3DOXO · Traditional	Ge Oec Medical Systems, Inc.	03/05/2021SE

More from Ge Oec Medical Systems, Inc.

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K253780	SIGNA BoltLNH · Traditional	02/06/2026SE
K253779	SIGNA Sprint SelectLNH · Traditional	02/05/2026SE
K252379	AIR Recon DLLNH · Traditional	12/23/2025SE
K251399	SIGNA SprintLNH · Traditional	09/11/2025SE
K250941	Revolution VibeJAK · Traditional	08/01/2025SE
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Questions and answers

When was Accent 16, Accent 22 cleared by the FDA?

Accent 16, Accent 22 (K980322) received a 510(k) decision of Substantially Equivalent on April 24, 1998, 87 days after the submission was received.

What is the product code of K980322?

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.