Coronis Fusion 4 MP K9301629A

GUDID 05415334028845

MDCC-4430 MDT

Barco NV

Radiology picture archiving and communication system workstation Radiology picture archiving and communication system workstation Radiology picture archiving and communication system workstation Radiology picture archiving and communication system workstation Radiology picture archiving and communication system workstation Radiology picture archiving and communication system workstation Radiology picture archiving and communication system workstation Radiology picture archiving and communication system workstation Radiology picture archiving and communication system workstation Radiology picture archiving and communication system workstation Radiology picture archiving and communication system workstation Radiology picture archiving and communication system workstation Radiology picture archiving and communication system workstation Radiology picture archiving and communication system workstation
Primary Device ID05415334028845
NIH Device Record Key78eb3cae-f621-4f53-87ee-6b7a106891af
Commercial Distribution StatusIn Commercial Distribution
Brand NameCoronis Fusion 4 MP
Version Model NumberMDCC-4430
Catalog NumberK9301629A
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

Device Identifiers

Device Issuing AgencyDevice ID
GS105415334028845 [Primary]
GS105415334028845 [Primary]
GS105415334028845 [Primary]
GS105415334028845 [Primary]
GS105415334028845 [Primary]
GS105415334028845 [Primary]
GS105415334028845 [Primary]
GS105415334028845 [Primary]
GS105415334028845 [Primary]
GS105415334028845 [Primary]
GS105415334028845 [Primary]
GS105415334028845 [Primary]
GS105415334028845 [Primary]
GS105415334028845 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

PGYDisplay, diagnostic radiology
PGYDisplay, diagnostic radiology
PGYDisplay, diagnostic radiology
PGYDisplay, diagnostic radiology
PGYDisplay, diagnostic radiology
PGYDisplay, diagnostic radiology
PGYDisplay, diagnostic radiology
PGYDisplay, diagnostic radiology
PGYDisplay, diagnostic radiology
PGYDisplay, diagnostic radiology
PGYDisplay, diagnostic radiology
PGYDisplay, diagnostic radiology
PGYDisplay, diagnostic radiology
PGYDisplay, diagnostic radiology

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-07-31
Device Publish Date2020-07-23

On-Brand Devices [Coronis Fusion 4 MP]

05415334002340MDCC-4430
05415334028845MDCC-4430 MDT
05415334025981MDCC-4430 NC

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