O-armTM O2 Imaging System

Name: O-armTM O2 Imaging System
Brand: O-armTM O2 Imaging System

3manufacturers in China registered for this device type

1catalogue number

Who Else Makes It

Concentrated in Beijing (2), Shanghai (1).

Chinese manufacturers registered for FDA product code OXO
Manufacturer	City	Province	Registered as	Device types
GE Hangwei Medical Systems Co., Ltd.	Beijing	Beijing	Specification developer	22
GE Healthcare (China) Co., Ltd.	Beijing	Beijing	Specification developer	22
Siemens Shanghai, Medical Equipment Ltd.	Shanghai	Shanghai	Contract manufacturer	10

Record

Regulatory record for O-armTM O2 Imaging System
Listed by	Medtronic Navigation, Inc., United States
FDA product code	OXO
Device type	Image-Intensified Fluoroscopic X-Ray System, Mobile
Device class	Class 2
Regulation	21 CFR 892.1650
Establishment	Specification developer, Repacker / relabeller, Manufacturer
510(k)	K240465
Record published	2024-08-26

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Prescription	Prescription only
Label carries	serial number
Storage	Storage environment temperature -10 to 40 °C; Storage environment humidity 10 to 80 % RH
Sizes	Weight 1087 kg

Catalogue Numbers

Catalogue numbers for O-armTM O2 Imaging System
Catalogue number	Size	Status
BI70002000	Weight 1087.0 kg	In distribution

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
O-ARM®	Medtronic Navigation, Inc.	16
Cios Select	Siemens Shanghai, Medical Equipment Ltd.	3
Smart-C	Turner Imaging Systems, Inc.	3
Zenition	Philips Medical Systems Nederland B.V.	2
Broach Set SPX1	Ecential Robotics	2
Image-Intensified Fluoroscopic X-Ray System, Mobile	Ecotron Co., Ltd.	2
Flourocsan InSight	Hologic, Inc.	2
Genoray	Genoray Co., Ltd.	2
3D Imaging Set SPX1	Ecential Robotics	2
Discovery	GE Medical Systems, LLC	2
OEC	Ge Hualun Medical Systems Co., Ltd.	2
Cios Alpha	Siemens Healthcare Limited	1

Showing 12 of 40. All products under Image-Intensified Fluoroscopic X-Ray System, Mobile

Recalls Naming This Product

2 recalls name this product by its own identifiers, the 510(k) it is cleared under.

Recalls naming the identifiers of O-armTM O2 Imaging System
Recalled by	Identified by	Initiated	FDA class	Root cause	Reason	Quantity
Medtronic Navigation, Inc. (Boxborough)	510(k) number	2026-05-19	Class II	Under Investigation by firm	Potential for image artifacts caused by an anomaly in the O-arm O2 Imaging System s detector panel firmware.	589 units
Medtronic Navigation, Inc. (Boxborough)	510(k) number	2025-05-27	Class II	Under Investigation by firm	A mechanical component that supports the O2 gantry to the support structure in affected devices may have been damaged during manufacture.	3 units

Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.