Dual-Mode Mobile C-Arm (Geelin500A, Geelin500M)

FDA 510(k) K251004 · Hefei Chimed Intelligent Machine Co., Ltd.

Substantially Equivalent

510(k) numberK251004

Submission

Device name
Dual-Mode Mobile C-Arm (Geelin500A, Geelin500M)
Applicant
Hefei Chimed Intelligent Machine Co., Ltd.
Hefei, CN
Received
April 1, 2025
Decision date
November 6, 2025
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
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
K192819OEC EliteOXO · Special Ge Oec Medical Systems, Inc.11/08/2019SE

Questions and answers

When was Dual-Mode Mobile C-Arm (Geelin500A, Geelin500M) cleared by the FDA?

Dual-Mode Mobile C-Arm (Geelin500A, Geelin500M) (K251004) received a 510(k) decision of Substantially Equivalent on November 6, 2025, 219 days after the submission was received.

What is the product code of K251004?

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.