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., Orthoscan, Inc. and Beijing East Whale Imaging Technology Co., Ltd..

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 Nov 24, 2017
Skan-C Mobile C-Arm X-Ray System - 230V Variant, Skan-C Mobile C-Arm X-Ray System - 110V Variant
K170946
Skanray Technologies Private Limited
Radiology · 239d
Cleared Nov 16, 2017
OEC Elite
K172550
Ge Oec Medical Systems, Inc.
Radiology · 85d
Cleared Jul 12, 2017
OEC Elite MiniView
K171800
Ge Hualun Medical Systems Co. , Ltd.
Radiology · 26d
Cleared Jan 04, 2017
B6
K163429
Beijing East Whale Imaging Technology Co., Ltd.
Radiology · 28d
Cleared Jul 20, 2016
MultiScan G-Arm System
K160984
Beijing East Whale Imaging Technology Co., Ltd.
Radiology · 104d
Cleared Jun 21, 2016
OEC Elite MiniView
K160131
Ge Hangwei Medical Systems Co., Ltd.
Radiology · 153d
Cleared May 20, 2016
GEMSS Medical System Surgical Mobile Fluoroscopic X-ray System
K160065
Gemss Medical Systems Co., Ltd.
Radiology · 128d
Cleared Sep 30, 2015
MultiScan G-Arm System
K151280
Beijing East Whale Imaging Technology Co., Ltd.
Radiology · 139d
Cleared Jul 31, 2014
DIGIARC 100AU+
K141672
Beijing East Whale Imaging Technology Co., Ltd.
Radiology · 38d
Cleared Mar 28, 2014
ORTHOSCAN FD MINI C-ARM
K133174
Orthoscan, Inc.
Radiology · 162d

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 →