DynaCAD Lung Server

GUDID 04260483290121

2.3.0.224889, Release date: 2017-12-13 2.3.1.239548, Release date: 2019-10-01

MeVis Medical Solutions AG

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• Primary Device ID: 04260483290121
• NIH Device Record Key: f1ac374f-945f-406c-aa94-a414803bdd85
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DynaCAD Lung Server
• Version Model Number: 2.3
• 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	04260483290121 [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: 6
• Public Version Date: 2020-01-09
• Device Publish Date: 2017-12-21

On-Brand Devices [DynaCAD Lung Server]

• 04260483290121: 2.3.0.224889, Release date: 2017-12-13 2.3.1.239548, Release date: 2019-10-01
• 04260483290060: 2.2