Veolity

GUDID 04260483290244

2.2.0, Release date 2024-12-20

MeVis Medical Solutions AG

Radiology DICOM image processing application software

• Primary Device ID: 04260483290244
• NIH Device Record Key: 3f41b26b-e95c-4d57-9033-69cc0defab7b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Veolity
• Version Model Number: 2.2
• 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: 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	04260483290244 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K201501

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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-01-17
• Device Publish Date: 2025-01-09

On-Brand Devices [Veolity]

• 04260483290091: 1.4
• 04260483290039: 1.3
• 04260483290176: 1.7
• 04260483290244: 2.2.0, Release date 2024-12-20