Visage Breast Density

GUDID 04251332930008

Visage Imaging GmbH

Radiology PACS software

• Primary Device ID: 04251332930008
• NIH Device Record Key: 5c335224-0a3e-4bef-b07e-d912fc0215b3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Visage Breast Density
• Version Model Number: 1.0
• 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	04251332930008 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K201411

FDA Product Code

• QIH: Automated Radiological Image Processing Software

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: 2021-05-10
• Device Publish Date: 2021-04-30

Devices Manufactured by Visage Imaging GmbH

• 04251332920047 - Visage Ease Pro: 2024-03-08
• 04251332910055 - Visage 7: 2023-10-18
• 04251332910086 - Visage 7: 2023-06-23
• 04251332920030 - Visage Ease Pro: 2023-06-23
• 04251332910079 - Visage 7: 2022-02-24
• 04251332930008 - Visage Breast Density: 2021-05-10
• 04251332930008 - Visage Breast Density: 2021-05-10
• 04251332910062 - Visage 7: 2021-05-07
• 04251332920023 - Visage Ease Pro: 2020-03-17