Who else makes this device?

Name: Ox-Imager
Brand: Ox-Imager

Cardiovascular › MonitoringOximeter, Tissue Saturation

Ox-Imager

The Ox-Imager CS™ is intended for use by healthcare professionals as a noninvasive tissue oxygenation measurement system that maps value of: oxygen saturation, oxy-hemoglobin, and…

Registry build 21.09.26

The Ox-Imager CS™ is intended for use by healthcare professionals as a noninvasive tissue oxygenation measurement system that maps value of: oxygen saturation, oxy-hemoglobin, and deoxy-hemoglobin into 2D/3D visual presentations.

5manufacturers in China registered for this device type

1catalogue number

2510(k) clearances naming this product code

Who Else Makes It

Concentrated in Guangdong (2), Jiangsu (2), Sichuan (1). 3 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code MUD
Manufacturer	City	Province	Registered as	Device types
Amphenol Medical Technologies (Dongguan) Co., Ltd.	Dongguan	Guangdong	Contract manufacturer	77
Jiangyin Sinbon Electronics Co Ltd	Jiangyin	Jiangsu	Contract manufacturer	13
Measurement Specialties Chengdu	Chengdu	Sichuan	Contract manufacturer	3
Shenzhen Mindray BIO-Medical Electronics Co., Ltd.	Shenzhen	Guangdong	Specification developer	61
GE Medical Systems (China) Co., Ltd.	Wuxi	Jiangsu	Contract manufacturer	57

Record

Regulatory record for Ox-Imager
Listed by	Modulated Imaging, Inc., United States
FDA product code	MUD
Device type	Oximeter, Tissue Saturation
Device class	Class 2
Regulation	21 CFR 870.2700
Establishment	Complaint-file establishment, Manufacturer
Record published	2018-01-19
Record revised	2020-07-01 (version 5)

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Prescription	Prescription only
Label carries	manufacturing date, serial number
Distribution end date	2019-10-15

Catalogue Numbers

Catalogue numbers for Ox-Imager
Catalogue number	Size	Status
CS		Withdrawn

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
Invos	Covidien LP	54
Nonin	Nonin Medical, Inc.	30
Fore-Sight Elite®	Cas Medical Systems, Inc.	12
Fore-Sight®	Cas Medical Systems, Inc.	9
ForeSight	Edwards Lifesciences Technology Sarl	7
Spectros T-Stat	Spectros Corporation	7
Component Neuromonitoring System	Moberg Research, Inc.	6
HyperView	Hypermed Imaging, Inc.	6
O3	Masimo Corporation	5
Mespere	Mespere Lifesciences Inc.	3
SnapshotNIR	Kent Imaging Inc	2
Moor Instruments Ltd	Moor Instruments Ltd.	2

Showing 12 of 30. All products under Oximeter, Tissue Saturation

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance	Decision date
K181623	2018-07-19
K153426	2016-12-21

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.