Vitrea

GUDID 00853866003179

Vitrea® is a medical diagnostic system that allows the processing, review, analysis, communication and media interchange of digital images acquired from a variety of imaging devices. Vitrea is not meant for primary image interpretation in mammography. Vitrea provides visualization of digital images to aid clinicians in their analysis of anatomy and pathology. The Vitrea user interface follows typical clinical workflow patterns to process, review, and analyze digital images. It is a web-based imaging system that allows physicians to use PCs or notebook computers to remotely access to 2D and 3D advanced visualization using a Microsoft web-enabled browser. Vitrea modules include automated and semi-automated visualization and advanced quantification tools targeted for a specific study based on a protocol selected by the user. The automation is only intended to reduce the manual steps required by the user to analyze and quantify the data from the images; it is not intended to detect pathology or disease. The software provides imaging information as an assist to the physician.

VITAL IMAGES, INC.

Radiology PACS software

• Primary Device ID: 00853866003179
• NIH Device Record Key: a9f0323e-5e3a-40a2-a1ac-04a80a690d8a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Vitrea
• Version Model Number: 6.9
• 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	00853866003179 [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: 2016-11-07

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