Visia LungCAD

GUDID 04260483290084

MeVis Medical Solutions AG

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• Primary Device ID: 04260483290084
• NIH Device Record Key: 14dbb847-d383-4bd9-9dd2-300ad90063f2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Visia LungCAD
• Version Model Number: 5.8
• Company DUNS: 315042296
• Company Name: MeVis Medical Solutions AG
• 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	04260483290084 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K043617

FDA Product Code

• OEB: Lung Computed Tomography System, Computer-Aided Detection

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: 2019-10-07
• Device Publish Date: 2017-12-21

On-Brand Devices [Visia LungCAD]

• 04260483290084: 5.8
• 04260483290015: 5.7