Radiology › DiagnosticInterventional Fluoroscopic X-Ray System

ImagingRing M

Name: ImagingRing m
Brand: ImagingRing m

ImagingRing m, Version 2: Mobile (within an imaging facility) assembly of diagnostic x-ray computed tomography (CT) and fluoroscopic devices intended to acquire, display and process both:…

Registry build 21.09.26

ImagingRing m, Version 2: Mobile (within an imaging facility) assembly of diagnostic x-ray computed tomography (CT) and fluoroscopic devices intended to acquire, display and process both: 1) two- and/or three-dimensional (3-D) cross-sectional (tomographic) images; and 2) real-time fluoroscopic images, from any part of the body for a variety of applications.

5manufacturers in China registered for this device type

2catalogue numbers in this listing

2510(k) clearances naming this product code

Who Else Makes It

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

Chinese manufacturers registered for FDA product code OWB
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
Shanghai United Imaging Healthcare Co., Ltd.	Shanghai	Shanghai	Manufacturer	12
Siemens Shanghai, Medical Equipment Ltd.	Shanghai	Shanghai	Contract manufacturer	10
Siemens Shenzhen Magnetic Resonance Ltd.	Shenzhen	Guangdong	Contract manufacturer	8

Record

Regulatory record for ImagingRing m
Listed by	Medphoton Gmbh, Austria
FDA product code	OWB
Device type	Interventional Fluoroscopic X-Ray System
Device class	Class 2
Regulation	21 CFR 892.1650
Establishment	Manufacturer
510(k)	K203281
Record published	2021-03-22
Record revised	2022-02-21 (version 3)

Specifications

Specifications
MRI safety	MR Unsafe
Prescription	Prescription only
Label carries	manufacturing date, serial number

Catalogue Numbers

Catalogue numbers for ImagingRing m
Catalogue number	Size	Status
1		In distribution
2		In distribution

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
TrackX	Trackx Technology Inc.	86
Trinias	Shimadzu Corp.	54
Allura Xper FD	Philips Medical Systems Nederland B.V.	21
Azurion	Philips Medical Systems Nederland B.V.	19
LessRay	Nuvasive, Inc.	16
Intelli-C Accessory	Nrt – Nordisk Røntgen Teknik A/S	13
Pulse	Nuvasive, Inc.	12
O-ARM®	Medtronic Navigation, Inc.	11
Genoray	Genoray Co., Ltd.	10
Fujifilm Healthcare Americas Corporation	A.T.S. Applicazione Tecnologie Speciali SRL	7
Fujifilm Medical Systems U.S.A. Inc.	A.T.S. Applicazione Tecnologie Speciali SRL	6
Stephanix	A.T.S. Applicazione Tecnologie Speciali SRL	6

Showing 12 of 122. All products under Interventional Fluoroscopic X-Ray System

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance	Decision date
K234067	2025-03-28
K203281	2020-12-22

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.