FDA.reportPublic FDA data

Clinical review 2MP

Primary DI
05415334000520
Brand
Clinical review 2MP
Company
Barco NV
Model
MDRC-2224 WP
Catalog number
K9303004A
Published
2016-06-30
Public version status
Update
Distribution status
Not 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
05415334000520PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05415334000520054153340005205415334000520

GMDN Terms#

Term, Definition table
TermDefinition
Image display monitor, colourA mains electricity (AC-powered) visual display unit (VDU), commonly known as a screen or a monitor, used for displaying graphical information under program control in colour, e.g., measured values or images from other devices. Colour is necessary when separating the information of multiple parameters making it easier for the user to read the values. A keyboard may be connected to the unit for interactive manipulation of the data by an operator. This GMDN code is the product identifier for the monitor only, which will not include the device(s) from which the data is generated and includes different screen technologies, e.g., cathode-ray tube (CRT) or liquid crystal display (LCD).

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
DM exempt
true
Premarket exempt
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05415334057265Nio Color 8MPMDNC-8132K9300830B2X2026-05-07
05415334062412Nexxis ORNexxis systemK96104262026-04-28
05415334036277Nexxis ORNexxis systemK96104202021-06-28
05415334057258Eonis 32”MDRC-8132K9350830B2X2026-04-13
05415334050020BarcoMDSC-8532 K93530182025-12-22
05415334000148Nio 2MPE 2620 S2016-06-30
05415334050013BarcoMDSC-8532K93530192025-12-01
05415334053045Eonis 3DMDRC-8127K9301153A2X2025-12-01
05415334060159Nio 5.8MP GrayMDNG-6221K9300375C1X2025-12-01
05415334000155Barco Mammo TomosynthesisMDMG-52212016-06-30
05415334000162Coronis 3MP LEDMDCG-32212016-06-30
05415334000247Coronis Fusion 4MP LEDMDCC-4330K9301625A2016-06-30
05415334000261Coronis Fusion 6MP LEDMDCC-6430K9301635A2016-06-30
05415334000339Nio 3MP LEDMDNG-3220K9301860A2016-06-30
05415334000353Nio 3MP LEDMDNG-3220K9301862A2016-06-30
05415334000360Nio 3MP LEDMDNG-3220K9301863A2016-06-30
05415334000513Coronis Fusion 6MP LEDMDCC-6430K9301635B2016-08-30
05415334001077NexxisMNA-110K9303177A2016-06-30
05415334054967Nio 5.8MP ColorMDNC-6121K9300360C1X2025-08-11
05415334054974Nio 5.8MP ColorMDNC-6121K9300361C1X2025-08-11

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
00818834028837MiiS Horus Endoscope Display System -Video BoxTRI-ANIM HEALTH SERVICES, INC.LMD2025-08-12
08800184000009I-Rapha ViewIRM IncLMD2025-08-01