FDA.reportPublic FDA data

Eonis 3D

Primary DI
05415334053045
Brand
Eonis 3D
Company
Barco NV
Model
MDRC-8127
Catalog number
K9301153A2X
Device description
MDRC-8127 SLIB
Published
2025-12-01
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

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
05415334053045PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05415334053045054153340530455415334053045

GMDN Terms#

Term, Definition table
TermDefinition
Image display unit, colourAn electrically-powered visual display unit (VDU), commonly known as a screen or a monitor [e.g., cathode-ray tube (CRT) or liquid crystal display (LCD)], designed for displaying graphical information (e.g., values or images measured/acquired by other devices) in colour. The device(s) that generates the visual data is not included with the display unit.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1 866-302-7939service.medical.usa@barco.com

Regulatory Flags#

DUNS number
371618773
Device count
1
Premarket exempt
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05415334001671BarcoMDSC-8255K9307933022020-07-29
05415334001879BarcoMDSC-8255K9307930022020-07-29
05415334001886BarcoMDRC-2222K93079432020-07-29
05415334001961BarcoMDSC-8255K93079322020-07-29
05415334001978BarcoMDSC-2324K93079482020-07-29
05415334002098BarcoMDSC-2326K93079512020-07-29
05415334002104BarcoMDSC-2326K93079522020-07-29
05415334002227BarcoMDSC-2326K93079542020-07-29
05415334002913BarcoMDSC-2326K9307951B2020-07-29
05415334002920BarcoMDSC-2326K9307954B2020-07-29
05415334002982BarcoMDSC-8255K93520212020-07-29
05415334002999BarcoMDSC-8255K93520222020-07-29
05415334020948BarcoMDRC-2222K9307944BR2020-07-29
05415334023246BarcoMDRC-2222K9307947BR2020-07-29
05415334026537BarcoMDSC-8255K9352021B2020-07-29
05415334026544BarcoMDSC-8255K9307931B2020-07-29
05415334026551BarcoMDSC-8255K930793002B2020-07-29
05415334026612BarcoMDSC-8255K930793302B2020-07-29
05415334026629BarcoMDSC-8255K9307932B2020-07-29
05415334026636BarcoMDSC-8255K9352022B2020-07-29

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04056481144616Quip EyeBrainlab SELMD2026-08-25
04056481145804Brainlab Origin ORBrainlab SELMD2026-08-21
00850054590183interWORKSAvreo IncLMD2026-08-03
00850054590176interWORKSAvreo IncLMD2026-07-29
04056481147099Buzz O.R. ComputeBrainlab SELMD2026-07-09
00850054590169interWORKSAvreo IncLMD2026-07-08
B214CORELABV100CORELabmedimaps group SALMD2026-06-29
00850025268417Vitrea Advanced VisualizationCanon Medical Informatics, Inc.LMD2026-06-05
30009336010630Nissha Medical TechnologiesGRAPHIC CONTROLS ACQUISITION CORPLMD2026-06-01
00850025268424Vitrea Advanced VisualizationCanon 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 VisualizationCanon 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 VisualizationCanon Medical Informatics, Inc.LMD2026-01-21
05060634690072EchoGoULTROMICS LIMITEDLMD2026-01-14
00850054590152interWORKSAvreo IncLMD2025-12-08
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 VisualizationCanon Medical Informatics, Inc.LMD2025-11-03