Coronis 5MP LED K9301540C

GUDID 05415334030329

MDCG-5221 CB MKIII

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 ID: 05415334030329
• NIH Device Record Key: d35ac3fb-2c0f-478a-90eb-75271e5a576b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Coronis 5MP LED
• Version Model Number: MDCG-5221
• Catalog Number: K9301540C
• 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: 866-302-7939
• Email: service.medical.usa@barco.com
• Phone: 866-302-7939
• Email: service.medical.usa@barco.com
• Phone: 866-302-7939
• Email: service.medical.usa@barco.com
• Phone: 866-302-7939
• Email: service.medical.usa@barco.com
• Phone: 866-302-7939
• Email: service.medical.usa@barco.com
• Phone: 866-302-7939
• Email: service.medical.usa@barco.com
• Phone: 866-302-7939
• Email: service.medical.usa@barco.com
• Phone: 866-302-7939
• Email: service.medical.usa@barco.com
• Phone: 866-302-7939
• Email: service.medical.usa@barco.com
• Phone: 866-302-7939
• Email: service.medical.usa@barco.com
• Phone: 866-302-7939
• Email: service.medical.usa@barco.com
• Phone: 866-302-7939
• Email: service.medical.usa@barco.com
• Phone: 866-302-7939
• Email: service.medical.usa@barco.com
• Phone: 866-302-7939
• Email: service.medical.usa@barco.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	05415334030329 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K133984

FDA Product Code

• LLZ: System, Image Processing, Radiological

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: 2021-12-22
• Device Publish Date: 2021-12-14

Devices Manufactured by Barco NV

• 05415334044388 - Eonis Color 8MP: 2024-04-10 MDRC-8132
• 05415334049734 - Nio Fusion 12MP: 2024-02-29 MDNC-12130 H NC
• 05415334044289 - BARCO: 2023-12-27 MDPC-8127
• 05415334044371 - BARCO: 2023-12-27 MDPC-8127
• 05415334043725 - Nio Color 3MP: 2023-12-21 MDNC-3521 SNES
• 05415334043732 - Nio Color 3MP: 2023-12-21 MDNC-3521 SPES DE
• 05415334043749 - Nio Color 2MP: 2023-12-21 MDNC-2521 SPES
• 05415334043763 - Nio Color 2MP: 2023-12-21 MDNC-2521 SNES