DynaCAD Lung

GUDID 04260483290183

MeVis Medical Solutions AG

Radiology DICOM image processing application software

• Primary Device ID: 04260483290183
• NIH Device Record Key: 2f8c272a-d8b0-4448-90b8-9f47e52f1186
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DynaCAD Lung
• Version Model Number: 2.4
• 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: false
• 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	04260483290183 [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: 2021-03-26
• Device Publish Date: 2021-03-18

On-Brand Devices [DynaCAD Lung]

• 04260483290114: 2.3
• 04260483290053: 2.2
• 04260483290183: 2.4