Coronis Fusion 4MP K9301605A

GUDID 05415334001510

Barco NV

Radiology picture archiving and communication system workstation
Primary Device ID05415334001510
NIH Device Record Key26b3b196-5a62-49e6-bba0-05788264942b
Commercial Distribution StatusIn Commercial Distribution
Brand NameCoronis Fusion 4MP
Version Model NumberMDCC-4130
Catalog NumberK9301605A
Company DUNS371618773
Company NameBarco NV
Device Count1
DM Exempttrue
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(866)302-7939
Emailservice.medical.usa@barco.com
Phone+1(866)302-7939
Emailservice.medical.usa@barco.com
Phone+1(866)302-7939
Emailservice.medical.usa@barco.com
Phone+1(866)302-7939
Emailservice.medical.usa@barco.com
Phone+1(866)302-7939
Emailservice.medical.usa@barco.com
Phone+1(866)302-7939
Emailservice.medical.usa@barco.com
Phone+1(866)302-7939
Emailservice.medical.usa@barco.com
Phone+1(866)302-7939
Emailservice.medical.usa@barco.com
Phone+1(866)302-7939
Emailservice.medical.usa@barco.com
Phone+1(866)302-7939
Emailservice.medical.usa@barco.com
Phone+1(866)302-7939
Emailservice.medical.usa@barco.com
Phone+1(866)302-7939
Emailservice.medical.usa@barco.com
Phone+1(866)302-7939
Emailservice.medical.usa@barco.com
Phone+1(866)302-7939
Emailservice.medical.usa@barco.com
Phone+1(866)302-7939
Emailservice.medical.usa@barco.com
Phone+1(866)302-7939
Emailservice.medical.usa@barco.com

Device Identifiers

Device Issuing AgencyDevice ID
GS105415334001510 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LLZSystem, image processing, radiological

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2018-12-20
Device Publish Date2016-08-19

On-Brand Devices [Coronis Fusion 4MP]

05415334001510MDCC-4130
05415334034778MDCC-4430 NC
05415334034754MDCC-4430
05415334046610MDCC-4430 MDT
05415334044135MDCC-4430 NC
05415334044128MDCC-4430

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