OXO · Class II · 21 CFR 892.1650

FDA Product Code OXO: Image-intensified Fluoroscopic X-ray System, Mobile

Fluoroscopy Of The Human Body.

Leading manufacturers include Siemens Medical Solutions USA, Inc., Ge Hualun Medical Systems Co. , Ltd. and Ge Oec Medical Systems, Inc..

82
Total
82
Cleared
93d
Avg days
1976
Since
Growing category - 7 submissions in the last 2 years vs 1 in the prior period
Review times increasing: avg 164d recently vs 87d historically

FDA 510(k) Cleared Image-intensified Fluoroscopic X-ray System, Mobile Devices (Product Code OXO)

82 devices
1–24 of 82
Cleared Jun 05, 2026
Digital C-ARM with 3D
K253296
Allengers Medical Systems Limited
Radiology · 249d
Cleared Jan 14, 2026
Orthoscan TAU MVP Mini C-Arm System
K252579
Ziehm-Orthoscan, Inc.
Radiology · 152d
Cleared Nov 26, 2025
OEC One CFD
K253269
Ge Hualun Medical Systems Co. , Ltd.
Radiology · 58d
Cleared Nov 06, 2025
Dual-Mode Mobile C-Arm (Geelin500A, Geelin500M)
K251004
Hefei Chimed Intelligent Machine Co., Ltd.
Radiology · 219d
Cleared Jul 02, 2025
Orthoscan TAU Mini C-Arm
K250587
Ziehm-Orthoscan, Inc.
Radiology · 125d
Cleared Jan 14, 2025
Orthoscan VERSA Mini C-Arm
K243452
Ziehm-Orthoscan, Inc.
Radiology · 68d
Cleared Dec 27, 2024
OEC One ASD
K240828
Ge Hualun Medical Systems Co. , Ltd.
Radiology · 276d
Cleared Mar 28, 2024
OEC 3D
K233669
Ge Oec Medical Systems, Inc.
Radiology · 134d
Cleared Oct 21, 2021
Orthoscan Tau Mini C-Arm
K213113
Orthoscan, Inc.
Radiology · 24d
Cleared Mar 05, 2021
OEC 3D
K203346
Ge Oec Medical Systems, Inc.
Radiology · 112d
Cleared Nov 08, 2019
OEC Elite
K192819
Ge Oec Medical Systems, Inc.
Radiology · 38d
Cleared Sep 27, 2019
Smart-C
K190024
Turner Imaging Systems, Inc.
Radiology · 263d
Cleared Jun 21, 2019
OrthoScan TAU Mini C-Arm
K183220
Orthoscan, Inc.
Radiology · 213d
Cleared Nov 16, 2018
OEC One
K182626
Ge Hualun Medical Systems Co. , Ltd.
Radiology · 53d
Cleared Jun 01, 2005
ARCADIS AVANTIC
K051133
Siemens Medical Solutions USA, Inc.
Radiology · 29d
Cleared Feb 12, 2004
SIREMOBILE C06
K040066
Siemens Medical Solutions USA, Inc.
Radiology · 30d
Cleared Dec 01, 2000
SIREMOBIL ISO-C 3D
K003266
Siemens Medical Solutions USA, Inc.
Radiology · 44d
Cleared Nov 10, 1997
SIREMOBIL CO2
K973598
Siemens Medical Solutions USA, Inc.
Radiology · 49d
Cleared Sep 03, 1996
SIREMOBIL COMPACT
K963093
Siemens Medical Solutions USA, Inc.
Radiology · 26d
Cleared Oct 23, 1991
MOBILE X-RAY SYSTEM
K913525
Siemens Medical Solutions USA, Inc.
Radiology · 76d

About Product Code OXO - Regulatory Context

510(k) Submission Activity

82 total 510(k) submissions under product code OXO since 1976, with 82 receiving FDA clearance (average review time: 93 days).

Submission volume has increased in recent years - 7 submissions in the last 24 months compared to 1 in the prior period - suggesting growing market activity in this device classification.

FDA 510(k) Review Time - OXO Product Code

Recent submissions under OXO have taken an average of 164 days to reach a decision - up from 87 days historically. Manufacturers should account for longer review timelines in current project planning.

OXO devices are reviewed by the Radiology panel. Browse all Radiology devices →