FSN

Image Processing System

Registry build 21.09.26
6manufacturers in China registered for this device type
7catalogue numbers in this listing

Who Else Makes It

Concentrated in Jiangsu (4), Tianjin (1), Beijing (1). 2 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code LMD
Manufacturer City Province Registered as Device types
Coretronic Projection (Kunshan) Corporation Kunshan Jiangsu Contract manufacturer 3
AUO (Suzhou) Co., Ltd. Suzhou Jiangsu Contract manufacturer 1
Nanjing Jusha Display Technology Co., Ltd. Nanjing Jiangsu Manufacturer 7
Barco (Suzhou) Healthcare Technology Co., Ltd. Suzhou Jiangsu Contract manufacturer 4
Beijing Visual Perception Intelligence Technology Co., Ltd. Tianjin Tianjin Manufacturer 1
E-COM Technology Co., Ltd. Beijing Beijing Manufacturer 1

Record

Regulatory record for FSN
Listed by Foreseeson Custom Displays, Inc., United States
FDA product code LMD
Device type System, Digital Image Communications, Radiological
Device class Class 1
Regulation 21 CFR 892.2020
Establishment Remanufacturer, Repacker / relabeller, Complaint-file establishment, Manufacturer
Premarket notification Exempt
Record published 2022-09-29
Record revised 2023-07-06 (version 3)

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Label carries lot or batch number, manufacturing date, serial number

Catalogue Numbers

Catalogue numbers for FSN
Catalogue number Size Status
IPS4000 In distribution
WUH4000 (RX) In distribution
IPS720 In distribution
WUH4000 (TX) In distribution
IPS740DG, IPS740DS In distribution
IPS100A In distribution
IPS500A In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Vitrea Advanced Visualization Canon Medical Informatics, Inc. 34
Barco Barco, Inc 27
RadiForce® Eizo Corporation 23
Vitrea Read Canon Medical Informatics A/S 19
Image Diagnostics, Inc Image Diagnostics, Inc. 19
ScaleOR NDS Surgical Imaging, LLC. 17
interWORKS Avreo, Inc. 16
Vitrea View Canon Medical Informatics, Inc. 14
Clinical review 2MP Barco, Inc 11
Barco Fimi SRL 10
Super Ulstar Durico C&T, Inc. 9
VISIUSmatrix Imris Imaging, Inc. 9

Showing 12 of 193. All products under System, Digital Image Communications, Radiological

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.

Where China Actually Supplies

Every device page names the company that lists it and the factories registered to make the same thing. These are the sections with the most of them.

5,100manufacturers registered in China
2,581device types they are registered for
340,248device records, each naming its maker
31provinces with a registered manufacturer