Orthoscan Mobile Di Mini C-Arm

Q: What is the product code of K113708?

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) K113708 · Orthoscan, Inc.

Substantially Equivalent

510(k) numberK113708

Submission

Device name: Orthoscan Mobile Di Mini C-Arm
Applicant: Orthoscan, Inc.
Scottsdale, AZ, US
Received: December 16, 2011
Decision date: January 5, 2012
Decision: Substantially Equivalent (SESE)
Type: Traditional 510(k)
Summary: 510(k) statement available from FDA
Third-party review: Yes

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.

510(k)	Device	Decision
K213113	Orthoscan Tau Mini C-ArmOXO · Special	10/21/2021SE
K183220	OrthoScan TAU Mini C-ArmOXO · Traditional	06/21/2019SE
K133174	Orthoscan FD Mini C-ArmOXO · Traditional	03/28/2014SE
K051754	Orthoscan, Orthoscan HDOXO · Traditional	08/09/2005SE
K011827	Ortelius 800KQX · Traditional	08/28/2001SE

Questions and answers

When was Orthoscan Mobile Di Mini C-Arm cleared by the FDA?

Orthoscan Mobile Di Mini C-Arm (K113708) received a 510(k) decision of Substantially Equivalent on January 5, 2012, 20 days after the submission was received.

What is the product code of K113708?

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.