Intuitive Workflow Tools K9308260

GUDID 05415334002050

accessories for image enhancement in diagnostic displays

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 ID05415334002050
NIH Device Record Keyadf3d28a-b71e-4244-8bf1-d72594580eba
Commercial Distribution StatusIn Commercial Distribution
Brand NameIntuitive Workflow Tools
Version Model Number2.X.X.X
Catalog NumberK9308260
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 Numberfalse
Manufacturing Datefalse
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
GS105415334002050 [Primary]
GS105415334002050 [Primary]
GS105415334002050 [Primary]
GS105415334002050 [Primary]
GS105415334002050 [Primary]
GS105415334002050 [Primary]
GS105415334002050 [Primary]
GS105415334002050 [Primary]
GS105415334002050 [Primary]
GS105415334002050 [Primary]
GS105415334002050 [Primary]
GS105415334002050 [Primary]
GS105415334002050 [Primary]
GS105415334002050 [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

Devices Manufactured by Barco NV

05415334001091 - Barco2020-08-06 MDSC-8331 LED ISM
05415334001145 - Barco2020-08-06 MDRC-1219 TS
05415334001152 - Barco2020-08-06 MDRC-1219
05415334001176 - Barco2020-08-06 MDSC-8358 MNAG ST
05415334001329 - Barco2020-08-06 AR-3250-3206
05415334001343 - Barco2020-08-06 AR-3250-3209
05415334001350 - Barco2020-08-06 MDSC-8231 12G
05415334001367 - Barco2020-08-06 MDSC-8231 12G

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