OXO

Image-Intensified Fluoroscopic X-Ray System, Mobile

Product code
OXO
Device name
Image-Intensified Fluoroscopic X-Ray System, Mobile
Device class
Class 2
21 CFR
21 CFR 892.1650
Medical specialty
Radiology
Marketing pathway
510(K)
Flag
Third-party review eligible
510(k) clearances (last 3 years)
8
Summaries archived here
8 (direct download)
510(k) clearances (all years, FDA)
82 (all years; only the last 3 years are listed here)

FDA classification definition

Fluoroscopy of the human body.

Definition text from the FDA device classification database (U.S. federal government work, public domain).

510(k) clearances, last 3 years (8)

Last three years. Most recent: 2026-06-05.

NumberDecision dateApplicantDevice nameSummary
K2532962026-06-05Allengers Medical Systems LimitedDigital C-ARM with 3DPDF
K2525792026-01-14Ziehm-Orthoscan, Inc.Orthoscan TAU MVP Mini C-Arm SystemPDF
K2532692025-11-26Ge Hualun Medical Systems Co. , Ltd.OEC One CFDPDF
K2510042025-11-06Hefei Chimed Intelligent Machine Co., Dual-Mode Mobile C-Arm (Geelin500A, Geelin500M)PDF
K2505872025-07-02Ziehm-Orthoscan, Inc.Orthoscan TAU Mini C-ArmPDF
K2434522025-01-14Ziehm-Orthoscan, Inc.Orthoscan VERSA Mini C-ArmPDF
K2408282024-12-27Ge Hualun Medical Systems Co. , Ltd.OEC One ASDPDF
K2336692024-03-28Ge Oec Medical Systems, Inc.OEC 3DPDF

8 summaries are archived here for direct download.

Official FDA classification page: OXO
Classification and pathway per current FDA publications. Data from openFDA (CC0).