Visage Ease Pro

GUDID 04251332920009

Visage Imaging GmbH

Radiology picture archiving and communication system application software

• Primary Device ID: 04251332920009
• NIH Device Record Key: 53ef2193-79a2-4f13-b9d6-ef4d6a7d2f91
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Visage Ease Pro
• Version Model Number: 1.8.2
• Company DUNS: 340229090
• Company Name: Visage Imaging GmbH
• 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: true
• 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: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	04251332920009 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K142196

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: 2018-09-24
• Device Publish Date: 2016-09-24

On-Brand Devices [Visage Ease Pro]

• 04251332920016: 1.10
• 04251332920009: 1.8.2
• 04251332920023: 1.12
• 04251332920030: 2.0
• 04251332920047: 2.2