Visage 7

GUDID 04251332910086

Visage Imaging GmbH

Radiology PACS software

• Primary Device ID: 04251332910086
• NIH Device Record Key: a986da32-0fc6-44d1-8936-d39f0db171e7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Visage 7
• Version Model Number: 7.1.18
• 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: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	04251332910086 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K082269

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: 2023-06-23
• Device Publish Date: 2023-06-15

On-Brand Devices [Visage 7]

• 04251332910031: 7.1.12
• 04251332910024: 7.1.11
• 04251332910017: 7.1.10
• 04251332910000: 7.1.9
• 04251332910048: 7.1.14
• 04251332910062: 7.1.16
• 04251332910079: 7.1.17
• 04251332910086: 7.1.18
• 04251332910055: 7.1.15