MeVis Liver Suite

GUDID 04260483290268

MeVis Medical Solutions AG

Image segmentation application software

• Primary Device ID: 04260483290268
• NIH Device Record Key: 860c6ff1-5d65-47c5-9a8c-c4bf73a20629
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MeVis Liver Suite
• Version Model Number: 1.3
• 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: 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	04260483290268 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K232045

FDA Product Code

• JAK: System, X-Ray, Tomography, Computed

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: 2024-01-23
• Device Publish Date: 2024-01-15

Devices Manufactured by MeVis Medical Solutions AG

• 04260483290268 - MeVis Liver Suite: 2024-01-23
• 04260483290268 - MeVis Liver Suite: 2024-01-23
• 04260483290176 - Veolity: 2021-03-26
• 04260483290183 - DynaCAD Lung: 2021-03-26
• 04260483290169 - DynaSuite Neuro: 2020-01-16
• 04260483290121 - DynaCAD Lung Server: 2020-01-09 2.3.0.224889, Release date: 2017-12-13 2.3.1.239548, Release date: 2019-10-01
• 04260483290015 - Visia LungCAD: 2019-10-07
• 04260483290039 - Veolity: 2019-10-07
• 04260483290046 - Veolity LungCAD: 2019-10-07