MDNG-5121 CB (MA) K9300266C

GUDID 05415334001541

MDNG-5121 CB (MA)

Barco NV

Radiology picture archiving and communication system workstation

• Primary Device ID: 05415334001541
• NIH Device Record Key: 1412304a-40c9-47a4-a246-6f5a30d8807e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MDNG-5121 CB (MA)
• Version Model Number: MDNG-5121
• Catalog Number: K9300266C
• 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
• 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	05415334001541 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K062621

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

• 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