Product Code: OXO FDA class 2 21 CFR 892.1650

Image-Intensified Fluoroscopic X-Ray System, Mobile

Radiology

The Image-Intensified Fluoroscopic X-Ray System, Mobile is a portable radiology device used for real-time fluoroscopic imaging of the human body in clinical settings such as operating rooms and emergency departments. It is classified as Class 2 (FDA Class 2), requiring 510(k) premarket clearance, and is eligible for third-party review. The product code is OXO, with regulation number 892.1650 under the Radiology medical specialty.

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510(k)s

FEI Numbers

Registration Numbers

Unique Applicants

Years Active

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Basic Information

Product Code: OXO
Device Class: FDA class 2
Regulation Number: 892.1650
Medical Specialty: Radiology
Review Panel: RA
Submission Type: 1

Device Characteristics

✗

GMP Exempt

✗

Implant

✗

Life Sustain/Support

✓

Third Party

—

Summary Malfunction Reporting

Definition

Fluoroscopy of the human body.

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 82 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K253296	Digital C-ARM with 3D	Jun 05, 2026	Substantially Equivalent	Allengers Medical Systems Limited
K252579	Orthoscan TAU MVP Mini C-Arm System	Jan 14, 2026	Substantially Equivalent	Ziehm-Orthoscan, Inc.
K253269	OEC One CFD	Nov 26, 2025	Substantially Equivalent	Ge Hualun Medical Systems Co. , Ltd.
K251004	Dual-Mode Mobile C-Arm (Geelin500A, Geelin500M)	Nov 06, 2025	Substantially Equivalent	Hefei Chimed Intelligent Machine Co., Ltd.
K250587	Orthoscan TAU Mini C-Arm	Jul 02, 2025	Substantially Equivalent	Ziehm-Orthoscan, Inc.
K243452	Orthoscan VERSA Mini C-Arm	Jan 14, 2025	Substantially Equivalent	Ziehm-Orthoscan, Inc.
K240828	OEC One ASD	Dec 27, 2024	Substantially Equivalent	Ge Hualun Medical Systems Co. , Ltd.
K233669	OEC 3D	Mar 28, 2024	Substantially Equivalent	Ge Oec Medical Systems, Inc.
K213113	Orthoscan Tau Mini C-Arm	Oct 21, 2021	Substantially Equivalent	Orthoscan, Inc.
K203346	OEC 3D	Mar 05, 2021	Substantially Equivalent	Ge Oec Medical Systems, Inc.
K192819	OEC Elite	Nov 08, 2019	Substantially Equivalent	Ge Oec Medical Systems, Inc.
K190024	Smart-C	Sep 27, 2019	Substantially Equivalent	Turner Imaging Systems, Inc.
K183220	OrthoScan TAU Mini C-Arm	Jun 21, 2019	Substantially Equivalent	Orthoscan, Inc.
K182626	OEC One	Nov 16, 2018	Substantially Equivalent	Ge Hualun Medical Systems Co. , Ltd.
K170946	Skan-C Mobile C-Arm X-Ray System - 230V Variant, Skan-C Mobile C-Arm X-Ray System - 110V Variant	Nov 24, 2017	Substantially Equivalent	Skanray Technologies Private Limited
K172550	OEC Elite	Nov 16, 2017	Substantially Equivalent	Ge Oec Medical Systems, Inc.
K171800	OEC Elite MiniView	Jul 12, 2017	Substantially Equivalent	Ge Hualun Medical Systems Co. , Ltd.
K163429	B6	Jan 04, 2017	Substantially Equivalent	Beijing East Whale Imaging Technology Co., Ltd.
K160984	MultiScan G-Arm System	Jul 20, 2016	Substantially Equivalent	Beijing East Whale Imaging Technology Co., Ltd.
K160131	OEC Elite MiniView	Jun 21, 2016	Substantially Equivalent	Ge Hangwei Medical Systems Co., Ltd.
K160065	GEMSS Medical System Surgical Mobile Fluoroscopic X-ray System	May 20, 2016	Substantially Equivalent	Gemss Medical Systems Co., Ltd.
K151280	MultiScan G-Arm System	Sep 30, 2015	Substantially Equivalent	Beijing East Whale Imaging Technology Co., Ltd.
K141672	DIGIARC 100AU+	Jul 31, 2014	Substantially Equivalent	Beijing East Whale Imaging Technology Co., Ltd.
K133174	ORTHOSCAN FD MINI C-ARM	Mar 28, 2014	Substantially Equivalent	Orthoscan, Inc.
K131423	G-ARM MULTISCAN SYSTEM	Nov 07, 2013	Substantially Equivalent	Beijing East Whale Imaging Technology Co., Ltd.
K123603	OEC BRIVO 865 ADVANCE, OEC BRIVO 785 ESSENTIAL, AND OEC BRIVO 715 PRIME	May 17, 2013	Substantially Equivalent	Ge Healthcare Surgery GE Oec Medical Systems, Inc.
K121303	MOBILE C-ARM	Jul 26, 2012	Substantially Equivalent	Canon Inc. -Medical Equipment Group
K120613	OEC 9900 ELITE	Apr 06, 2012	Substantially Equivalent	Ge Healthcare Surgery GE Oec Medical Systems, Inc.
K120388	INSIGHT - FD MINI C-ARM FLUOROSCOPIC IMAGING SYSTEM	Apr 06, 2012	Substantially Equivalent	Hologic, Inc.
K113708	ORTHOSCAN MOBILE DI MINI C-ARM	Jan 05, 2012	Substantially Equivalent	Orthoscan, Inc.
K092564	O-ARM IMAGING SYSTEM	Jun 17, 2010	Substantially Equivalent	Medtronic Navigation, Inc. (Littleton)
K061873	VERT-X	Aug 18, 2006	Substantially Equivalent	Direx Systems Corp.
K060344	O-ARM IMAGING SYSTEM	Mar 29, 2006	Substantially Equivalent	Breakaway Imaging, LLC
K051754	ORTHOSCAN, ORTHOSCAN HD	Aug 09, 2005	Substantially Equivalent	Orthoscan, Inc.
K051490	GE OEC EVERVIEW 7500	Jul 07, 2005	Substantially Equivalent	Ge Oec Medical Systems, Inc.
K051133	ARCADIS AVANTIC	Jun 01, 2005	Substantially Equivalent	Siemens Medical Solutions USA, Inc.
K050996	O-ARM IMAGING SYSTEM	May 05, 2005	Substantially Equivalent	Breakaway Imaging, LLC
K043379	SHIMADZU SURGICAL MOBILE C-ARM IMAGING X-RAY SYSTEM, MODEL WHA-200	Feb 17, 2005	Substantially Equivalent	Shimadzu Corp.
K041213	3DSCOPE	Jul 22, 2004	Substantially Equivalent	Direx Systems Corp.
K040347	SIREMOBIL ISO-C 3D	Mar 09, 2004	Substantially Equivalent	Siemens Medical Systems, Inc.
K040066	SIREMOBILE C06	Feb 12, 2004	Substantially Equivalent	Siemens Medical Solutions USA, Inc.
K033066	XISCAN 4000 TRANSPORTABLE IMAGING SYSTEM	Nov 12, 2003	Substantially Equivalent	Xitec Holdings, LLC
K013426	MOONRAY MOBILE C-ARM	Mar 26, 2002	Substantially Equivalent	Simad S.R.L.
K010762	PHILIPS BV LIBRA	Apr 02, 2001	Substantially Equivalent	Philips Medical Systems, Inc.
K010393	APOLLO MOBILE C ARM SYSTEM	Mar 12, 2001	Substantially Equivalent	Cares Built, Inc.
K003837	FLEXIVIEW 8800 DIGITAL MOBILE IMAGING SYSTEM	Mar 12, 2001	Substantially Equivalent	Ge Oec Medical Systems
K003568	XISCAN 6000 IMAGING SYSTEM	Dec 27, 2000	Substantially Equivalent	Xitec, Inc.
K003266	SIREMOBIL ISO-C 3D	Dec 01, 2000	Substantially Equivalent	Siemens Medical Solutions USA, Inc.
K993092	SONADA ULTRASOUND SYSTEM	Apr 14, 2000	Substantially Equivalent	Sonovision Corp.
K992506	MINI 6800 DIGITAL MOBILE C-ARM	Aug 19, 1999	Substantially Equivalent	Ge Dec Medical Systems
K984406	XISCAN OFFICE EXPERT IMAGING SYSTEM, XISCAN SURGICAL EXPERT IMAGING SYSTEM	Feb 02, 1999	Substantially Equivalent	Xitec, Inc.
K982706	PHILIPS BV300 SERIES RELEASE 2.1	Sep 02, 1998	Substantially Equivalent	Philips Medical Systems, Inc.
K981131	PATHFINDER MOBILE C ARM	Jun 26, 1998	Substantially Equivalent	Acoma Medical Imaging, Inc.
K980322	ACCENT 16, ACCENT 22	Apr 24, 1998	Substantially Equivalent	GE Medical Systems
K973598	SIREMOBIL CO2	Nov 10, 1997	Substantially Equivalent	Siemens Medical Solutions USA, Inc.
K965013	DIGISCOPE RX-2 (9 OPTION)	Jan 17, 1997	Substantially Equivalent	Medirex, Inc.
K963093	SIREMOBIL COMPACT	Sep 03, 1996	Substantially Equivalent	Siemens Medical Solutions USA, Inc.
K960907	ORCA	May 20, 1996	Substantially Equivalent	Lunar Corp.
K955251	OEC 902, 901 NASA II, OEC 902, 901 NASA I CCD C-ARM	Apr 12, 1996	Substantially Equivalent	Imaging Services, Inc.
K960198	DIGISCOPE RX-2	Mar 12, 1996	Substantially Equivalent	Medirex, Inc.
K953910	PHILIPS BV 300 SERIES	Oct 18, 1995	Substantially Equivalent	Philips Medical Systems North America, Inc.
K951765	SERIES 6600 DIGITAL MOBILE C-ARM	May 11, 1995	Substantially Equivalent	Ge Dec Medical Systems
K940294	SHIMADZU MOBILE X-RAY SYSTEMS	Mar 16, 1994	Substantially Equivalent	Shimadzu Precision Instruments, Inc.
K935580	PHF20 20 MOBILE C-ARM IMAGE INTENSIFIER	Mar 16, 1994	Substantially Equivalent	Precise Optics
K934700	MODEL 90P PORTABLE MEDICAL DIAGNOSTIC X-RAY	Mar 16, 1994	Substantially Equivalent	Tempo Technology, Inc.
K933431	ORTHOTRAC COAXIAL LASER	Oct 05, 1993	Substantially Equivalent	Trac Medical, Inc.
K933447	STENOSCOP MOBILE FLUOROSCOPIC XRAY SYSTEM	Aug 23, 1993	Substantially Equivalent	GE Medical Systems
K926056	9600 FLUOROSCOPIC IMAGING SYSTEM	Jan 21, 1993	Substantially Equivalent	Oec-Diasonics, Inc.
K914748	COMET C-125	Oct 15, 1992	Substantially Equivalent	Fischer Imaging Corp.
K921255	PHILIPS BV26 MOBILE C-ARM STAND	May 18, 1992	Substantially Equivalent	Philips Medical Systems, Inc.
K913525	MOBILE X-RAY SYSTEM	Oct 23, 1991	Substantially Equivalent	Siemens Medical Solutions USA, Inc.
K911739	SWEMAC REISON BIPLANAR 300	Oct 23, 1991	Substantially Equivalent	Seemac Reison AB Co.
K910115	PHILIPS BV-29 IMAGING SYSTEM	Feb 20, 1991	Substantially Equivalent	Philips Medical Systems, Inc.
K900967	MODIFIED ALPHA MC-9R C-ARM	May 09, 1990	Substantially Equivalent	Instrumentarium Imaging, Inc.
K900193	MTHF-9R MOBIL C-ARM IMAGE INTENSIFIER UNIT	May 09, 1990	Substantially Equivalent	Imt America, Inc.
K900194	MTHF-9S MOBIL C-ARM IMAGE INTENSIFIER UNIT	May 07, 1990	Substantially Equivalent	Imt America, Inc.
K896387	SXT-60F/60M MOBILE C ARM X-RAY UNIT	Feb 23, 1990	Substantially Equivalent	Toshiba America Medical Systems, In.C
K892934	1 VIDEO TAPE RECORDER MODEL BK-224 H	Jul 20, 1989	Substantially Equivalent	Perkins Mfg. Co.
K893617	MOBILE C-ARM	Jul 14, 1989	Substantially Equivalent	Acoma Medical Imaging, Inc.
K880518	MOBILE C-ARM OMNI 325	Mar 09, 1988	Substantially Equivalent	Fischer Imaging Corp.
K820658	LIXISCOPE - OR LIXI	May 18, 1982	Substantially Equivalent	Lixi, Inc.
K760429	FLOUROSCOPE, MOBILE C-ARM IMAGE INTENS.	Aug 23, 1976	Substantially Equivalent	Varian Assoc., Inc.