Coronis OneLook K9301401A2X

GUDID 05415334046511

MDMC-32133 E

Barco NV

Radiology picture archiving and communication system workstation

• Primary Device ID: 05415334046511
• NIH Device Record Key: a63a5b87-c1dc-4378-8c5f-ecb8c9abf3c9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Coronis OneLook
• Version Model Number: MDMC-32133
• Catalog Number: K9301401A2X
• Company DUNS: 371618773
• Company Name: Barco NV
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1 866-302-7939
• Email: service.medical.usa@barco.com
• Phone: +1 866-302-7939
• Email: service.medical.usa@barco.com
• Phone: +1 866-302-7939
• Email: service.medical.usa@barco.com
• Phone: +1 866-302-7939
• Email: service.medical.usa@barco.com
• Phone: +1 866-302-7939
• Email: service.medical.usa@barco.com
• Phone: +1 866-302-7939
• Email: service.medical.usa@barco.com
• Phone: +1 866-302-7939
• Email: service.medical.usa@barco.com
• Phone: +1 866-302-7939
• Email: service.medical.usa@barco.com
• Phone: +1 866-302-7939
• Email: service.medical.usa@barco.com
• Phone: +1 866-302-7939
• Email: service.medical.usa@barco.com
• Phone: +1 866-302-7939
• Email: service.medical.usa@barco.com
• Phone: +1 866-302-7939
• Email: service.medical.usa@barco.com
• Phone: +1 866-302-7939
• Email: service.medical.usa@barco.com
• Phone: +1 866-302-7939
• Email: service.medical.usa@barco.com
• Phone: +1 866-302-7939
• Email: service.medical.usa@barco.com
• Phone: +1 866-302-7939
• Email: service.medical.usa@barco.com
• Phone: +1 866-302-7939
• Email: service.medical.usa@barco.com
• Phone: +1 866-302-7939
• Email: service.medical.usa@barco.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	05415334046511 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K242008

FDA Product Code

• PGY: Display, Diagnostic Radiology

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-10-08
• Device Publish Date: 2024-09-30

Devices Manufactured by Barco NV

• 05415334049895 - Coronis Fusion 4MP: 2025-04-24 MDCC-4430
• 05415334049901 - Coronis Fusion 4MP: 2025-04-24 MDCC-4430 NC
• 05415334049925 - Coronis Fusion 6MP: 2025-04-24 MDCC-6530
• 05415334049932 - Coronis Fusion 6MP: 2025-04-24 MDCC-6530 NC
• 05415334053717 - Barco: 2025-04-22 MDRC-2422 SNEW
• 05415334053724 - Barco: 2025-04-22 MDRC-2422 SPEW
• 05415334053731 - Barco: 2025-04-22 MDRC-2422 SNIB
• 05415334054059 - Barco: 2025-04-22 MDRC-2422 STIB