Coronis Fusion 10MP K9301660A

GUDID 05415334001497

Barco NV

Radiology picture archiving and communication system workstation

• Primary Device ID: 05415334001497
• NIH Device Record Key: 8877e224-f880-435d-8497-fe87450d3535
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Coronis Fusion 10MP
• Version Model Number: MDCG-10130
• Catalog Number: K9301660A
• Company DUNS: 371618773
• Company Name: Barco NV
• Device Count: 1
• DM Exempt: true
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	05415334001497 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K093197

FDA Product Code

• LLZ: System, image processing, radiological

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2018-12-20
• Device Publish Date: 2016-08-19

Devices Manufactured by Barco NV

• 05415334048553 - BARCO: 2025-01-10 MDEC-2523
• 05415334050358 - Nio Color 2MP: 2024-12-05 MDNC-2521 SPES
• 05415334050365 - Nio Color 2MP: 2024-12-05 MDNC-2521 SNES
• 05415334050372 - Nio Color 3MP: 2024-12-05 MDNC-3521 SPES
• 05415334050389 - Nio Color 3MP: 2024-12-05 MDNC-3521 SNES
• 05415334046511 - Coronis OneLook: 2024-10-08 MDMC-32133 E
• 05415334047716 - Eonis 22": 2024-10-08 MDRC-2422 STIB
• 05415334047723 - Eonis 22": 2024-10-08 MDRC-2422 SNEW