FDA.reportPublic FDA data

FSN

Primary DI
00810000890385
Brand
FSN
Company
FORESEESON CUSTOM DISPLAYS, INC.
Model
WUH4000 (TX)
Catalog number
WUH4000 (TX)
Device description
Wireless Imaging System
Published
2020-10-07
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
LMDSystem, Digital Image Communications, Radiological

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LMDSystem, Digital Image Communications, RadiologicalRadiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810000890385PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810000890385008100008903858100008903850810000890385

GMDN Terms#

Term, Definition table
TermDefinition
Medical networking interface unitAn electronic unit or device assembly intended to be used to interface multiple noninvasive devices for digital communication of clinical data, typically from a patient data gathering point (e.g., patient monitor, in vitro diagnostic analyser) to a computer/network server; it is not intended to store data, display data/images, or control other devices. It may be a router, network switch, wireless transmitter and/or receiver, or cellular device intended for wired and/or wireless transmission of data. It is not ambulatory and not patient worn.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
714-300-0540gudid@fsnmed.com

Regulatory Flags#

DUNS number
029368094
Device count
1
Premarket exempt
true
Lot or batch
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810000890675ArthrexWIS4100WIS41002026-05-08
00810000890712FSNFM-E3230D, FM-E3230DG, FM-E3230DNFM-E3230D, FM-E3230DG, FM-E3230DN2025-09-15
00810000890682FSNFS-E2102D, FS-E2102DTFS-E2102D, FS-E2102DT2024-06-26
00810000890699FSNFS-A2702D, FS-A2702DS, FS-A2702DT, FS-A2702DSTFS-A2702D, FS-A2702DS, FS-A2702DT, FS-A2702DST2024-06-26
00810000890705FSNFS-A3202D, FS-A3202DSFS-A3202D, FS-A3202DS2024-06-26
00810000890590FSNFM-F3101D, FM-F3101DGFM-F3101D, FM-F3101DG2024-03-12
00810000890606FSNFM-E2701D, FM-E2701DGFM-E2701D, FM-E2701DG2024-03-12
00810000890613FSNFM-E2701DT, FM-E2701DGTFM-E2701DT, FM-E2701DGT2024-03-12
00810000890620FSNFM-F2701D, FM-F2701DGFM-F2701D, FM-F2701DG2024-03-12
00810000890231FSNFM-C5501DVFM-C5501DV2022-08-19
00810000890262FSNFM-D5801DVFM-D5801DV2022-08-19
00810000890330FSNFM-D5802DVFM-D5802DV2022-08-19
00810000890347FSNFM-A5504DS, FM-A5504DGFM-A5504DS, FM-A5504DG2022-08-19
00810000890477FSNFM-E3204DGCFM-E3204DGC2022-08-19
00810000890514FSNFM-A5505DGCFM-A5505DGC2022-08-19
00810000890064FSNFS-P3102D, FS-P3102DS, FS-P3102DGFS-P3102D, FS-P3102DS, FS-P3102DG2022-08-02
00810000890156FSNFM-A2701D, FM-A2701DSFM-A2701D, FM-A2701DS2022-08-02
00810000890187FSNFM-B2702D, FM-B2702DGFM-B2702D, FM-B2702DG2022-08-02
00810000890415FSNFM-E3203D, FM-E3203DGFM-E3203D, FM-E3203DG2022-08-02
00810000890118FSNFS-P2603DFS-P2603D2022-07-18

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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30009336010630Nissha Medical TechnologiesGRAPHIC CONTROLS ACQUISITION CORPLMD2026-06-01
00850025268424Vitrea Advanced Visualization Canon Medical Informatics, Inc.LMD2026-05-12
08800026700890Medit AuraVueMedit Corp.LMD2026-05-11
00810111225663X-ray AppTreace Medical Concepts, Inc.LMD2026-05-01
00628105001212Vitrea ReadCanon Medical Informatics A/SLMD2026-04-27
05415334057258Eonis 32”Barco NVLMD2026-04-13
00628105001229Vitrea ReadCanon Medical Informatics A/SLMD2026-04-03
EPIS960010EpisurfViewEpisurf Operations ABLMD2026-03-17
07290018052402aiOSAIDOC MEDICAL LTDLMD2026-03-08
00850025268400Vitrea Advanced Visualization Canon Medical Informatics, Inc.LMD2026-02-27
04260483290312MammoScapeMeVis Medical Solutions AGLMD2026-02-16
00884838074798IntelliSpace PACS AnywherePhilips Medical Systems Nederland B.V.LMD2026-02-07
00850025268394Vitrea Advanced Visualization Canon Medical Informatics, Inc.LMD2026-01-21
05060634690072EchoGoULTROMICS LIMITEDLMD2026-01-14
00850054590152interWORKSAvreo IncLMD2025-12-08
05415334053045Eonis 3DBarco NVLMD2025-12-01
00628105001205Vitrea ReadCanon Medical Informatics A/SLMD2025-11-21
00850013331086SentiARSentiar, Inc.LMD2025-11-21
00850013331093SentiARSentiar, Inc.LMD2025-11-21
00850013331109SentiARSentiar, Inc.LMD2025-11-21
00850061871374IMAGE DIAGNOSTICS INCIMAGE DIAGNOSTICS, INC.LMD2025-11-18
00850054590145interWORKSAvreo IncLMD2025-11-14
00850025268387Vitrea Advanced Visualization Canon Medical Informatics, Inc.LMD2025-11-03
00850025268370Vitrea Advanced Visualization Canon Medical Informatics, Inc.LMD2025-09-24
00857534006868IMRISmatrix 5.0IMRIS Imaging, Inc.LMD2025-09-18
00857534006875IMRISmatrix 5.0IMRIS Imaging, Inc.LMD2025-09-18
03770024341072Sonio Pro v3SONIOLMD2025-08-28
00850054590138interWORKSAvreo IncLMD2025-08-26
00628105001199Vitrea ReadCanon Medical Informatics A/SLMD2025-08-15