Enterprise Imaging XERO Viewer XDFO2

GUDID 05414904242919

Agfa HealthCare NV

Radiology PACS software

• Primary Device ID: 05414904242919
• NIH Device Record Key: 8e31d8c4-b97c-4d4c-b413-bb96e596072c
• Commercial Distribution Discontinuation: 2019-07-22
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: Enterprise Imaging XERO Viewer
• Version Model Number: 8.1.1
• Catalog Number: XDFO2
• Company DUNS: 282853795
• Company Name: Agfa HealthCare 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: false
• Manufacturing Date: false
• 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(877)777-2432
• Email: salesinfo@agfa.com
• Phone: +1(877)777-2432
• Email: salesinfo@agfa.com
• Phone: +1(877)777-2432
• Email: salesinfo@agfa.com
• Phone: +1(877)777-2432
• Email: salesinfo@agfa.com
• Phone: +1(877)777-2432
• Email: salesinfo@agfa.com
• Phone: +1(877)777-2432
• Email: salesinfo@agfa.com
• Phone: +1(877)777-2432
• Email: salesinfo@agfa.com
• Phone: +1(877)777-2432
• Email: salesinfo@agfa.com
• Phone: +1(877)777-2432
• Email: salesinfo@agfa.com
• Phone: +1(877)777-2432
• Email: salesinfo@agfa.com
• Phone: +1(877)777-2432
• Email: salesinfo@agfa.com
• Phone: +1(877)777-2432
• Email: salesinfo@agfa.com
• Phone: +1(877)777-2432
• Email: salesinfo@agfa.com
• Phone: +1(877)777-2432
• Email: salesinfo@agfa.com
• Phone: +1(877)777-2432
• Email: salesinfo@agfa.com
• Phone: +1(877)777-2432
• Email: salesinfo@agfa.com
• Phone: +1(877)777-2432
• Email: salesinfo@agfa.com
• Phone: +1(877)777-2432
• Email: salesinfo@agfa.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	05414904242919 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K143397

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: 5
• Public Version Date: 2019-07-23
• Device Publish Date: 2018-03-14

On-Brand Devices [Enterprise Imaging XERO Viewer]

• 05414904252444: 8.1.2
• 05414904242919: 8.1.1
• 05414904218532: ENT IMG SW XERO VIEWER 8.1