FSN

Wireless Imaging System

Registry build 21.09.26
22manufacturers in China registered for this device type
25catalogue numbers in this listing

Who Else Makes It

Concentrated in Jiangsu (10), Guangdong (5), Shanghai (4). 5 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code KQM
Manufacturer City Province Registered as Device types
Dentall, Inc. District Beijing Contract manufacturer 13
Qisda Electronics (Suzhou) Co., Ltd. Suzhou Jiangsu Contract manufacturer 5
Barco (Suzhou) Healthcare Technology Co., Ltd. Suzhou Jiangsu Contract manufacturer 4
Coretronic Projection (Kunshan) Corporation Kunshan Jiangsu Contract manufacturer 3
Shanghai Suoguang Visual Products Co., Ltd. Shanghai Shanghai Contract manufacturer 1
Boen Healthcare Co., Ltd. Suzhou Jiangsu Specification developer 263
Suzhou Meccan Import and Export Corp. Suzhou Jiangsu Contract manufacturer 71
Gcmedica Enterprise Ltd.(Wuxi) Wuxi Jiangsu Contract manufacturer 55
Micro-Tech (Nanjing) Co., Ltd. Nan Jing Jiangsu Contract manufacturer 49
Lakong Medical Devices Co., Ltd. Dongguan Guangdong Remanufacturer 39
Jiangsu Guangda Medical Material Group Co., Ltd. Haian Jiangsu Contract manufacturer 32
Guilin Yikeshi Medical Device Co Ltd Guilin Guangxi Manufacturer 28

Showing 12 of 22. All 22 manufacturers in China registered for Camera, Surgical And Accessories

Record

Regulatory record for FSN
Listed by Foreseeson Custom Displays, Inc., United States
FDA product code KQM
Device type Camera, Surgical And Accessories
Device class Class 1
Regulation 21 CFR 878.4160
Establishment Remanufacturer, Repacker / relabeller, Complaint-file establishment, Manufacturer
Premarket notification Exempt
Record published 2022-07-18
Record revised 2024-05-03 (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
FS-P2603D In distribution
FS-E2101D, FS-E2101DT In distribution
FM-F3101D, FM-F3101DG In distribution
FM-E2701D, FM-E2701DG In distribution
FS-P2404D In distribution
FM-C5501DV In distribution
FS-A2702D, FS-A2702DS, FS-A2702DT, FS-A2702DST In distribution
FM-D5801DV In distribution
FS-A3202D, FS-A3202DS In distribution
FS-P2604D In distribution
FM-F2701D, FM-F2701DG In distribution
FS-P3102D, FS-P3102DS, FS-P3102DG In distribution
FM-E3230D, FM-E3230DG, FM-E3230DN In distribution
FM-A5504DS, FM-A5504DG In distribution
FM-D5802DV In distribution
FS-E2102D, FS-E2102DT In distribution
FM-A5505DGC In distribution
FM-A2701D, FM-A2701DS In distribution
WIS4000 In distribution
FM-E2701DT, FM-E2701DGT In distribution
FS-L2702D, FS-L2702DT In distribution
FM-E3204DGC In distribution
FM-E3203D, FM-E3203DG In distribution
FM-B2702D, FM-B2702DG In distribution
FS-L3202D In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Radiance NDS Surgical Imaging, LLC. 129
Accu-Beam Transamerican Technologies International 114
Barco Barco, Inc 89
Conmed ConMed Corporation 59
EndoVue NDS Surgical Imaging, LLC. 50
Sony Sony Corporation 42
CuratOR Eizo Corporation 38
ILO ILO Electronic Gmbh 25
Camera, Surgical And Accessories Pentax of America, Inc. 24
Beacon Shenzhen Beacon Display Technology Co., Ltd. 24
Tidishield Tidi Products, LLC 22
NDS Pentax of America, Inc. 19

Showing 12 of 190. All products under Camera, Surgical And Accessories

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