Radiology › DiagnosticImage-Intensified Fluoroscopic X-Ray System, Mobile

TAU Model 1000-0015 Mini C-Arm

Name: TAU Model 1000-0015 Mini C-Arm
Brand: TAU Model 1000-0015 Mini C-Arm

Catalogue number 1000-0015, listed by Ziehm-Orthoscan, Inc., United States, under Image-Intensified Fluoroscopic X-Ray System, Mobile. 3 manufacturers in China are registered for this product code.

Registry build 21.09.26

3manufacturers in China registered for this device type

1catalogue number

3510(k) clearances naming this product code

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 TAU Model 1000-0015 Mini C-Arm
Listed by	Ziehm-Orthoscan, 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
Record published	2021-05-27
Record revised	2023-08-02 (version 2)

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Prescription	Prescription only
Label carries	manufacturing date, serial number
Storage	Handling environment temperature 32 to 131 °F; Handling environment temperature 0 to 55 °C; Handling environment humidity 10 to 100 % RH; Storage environment atmospheric pressure 500 to 1600 millibar

Catalogue Numbers

Catalogue numbers for TAU Model 1000-0015 Mini C-Arm
Catalogue number	Size	Status
1000-0015		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

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance	Decision date
K252579	2026-01-14
K250587	2025-07-02
K243452	2025-01-14

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.