Vitrea

GUDID 00853866003216

Vitrea® software is an advanced visualization solution from Vital that creates 2D, 3D, and 4D images of human anatomy from image data from multiple modalities. With this tool, physicians can easily navigate within these images to better understand disease conditions. Vitrea addresses specialists’ needs through various software options for cardiac, colon, vessel probe, and other applications. In addition, Vitrea software utilizes an intuitive clinical workflow and automatic settings to improve speed and simplicity.

VITAL IMAGES, INC.

Radiology PACS software

• Primary Device ID: 00853866003216
• NIH Device Record Key: 056965df-2235-4585-ac8a-9a14f516ab72
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Vitrea
• Version Model Number: 7.3.2
• Company DUNS: 160061651
• Company Name: VITAL IMAGES, INC.
• 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: 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	00853866003216 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K032748

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: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2019-05-23
• Device Publish Date: 2016-12-22

On-Brand Devices [Vitrea]

• 00853866003254: Vitrea® is a medical diagnostic system that allows the processing, review, analysis, communicat
• 00853866003247: Vitrea® is a medical diagnostic system that allows the processing, review, analysis, communicat
• 00853866003216: Vitrea® software is an advanced visualization solution from Vital that creates 2D, 3D, and 4D i
• 00853866003209: Vitrea is a medical diagnostic system that allows the processing, review, analysis, communicatio
• 00853866003193: Vitrea is a medical diagnostic system that allows the processing, review, analysis, communicatio
• 00853866003186: Vitrea is a medical diagnostic system that allows the processing, review, analysis, communicatio
• 00853866003179: Vitrea® is a medical diagnostic system that allows the processing, review, analysis, communicat