Barco Mammo Tomosynthesis K9300521A

GUDID 05415334001534

MDMG-5221 CB

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 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: 05415334001534
• NIH Device Record Key: 0e4118bc-a0d4-4e97-b236-a57cc6b33c53
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Barco Mammo Tomosynthesis
• Version Model Number: MDMG-5221
• Catalog Number: K9300521A
• 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	05415334001534 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K103792

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

On-Brand Devices [Barco Mammo Tomosynthesis]

• 05415334001572: MDMG-5221 CB
• 05415334001565: MDMG-5221
• 05415334001534: MDMG-5221 CB
• 05415334001527: MDMG-5221 BB
• 05415334000155: MDMG-5221