Vitrea Advanced Visualization

GUDID 00850025268295

The Vitrea Advanced Visualization software is a medical diagnostic system that allows the processing, review, analysis, communication, and media interchange of multi-dimensional digital images acquired from a variety of imaging devices. The Vitrea Advanced Visualization system provides multi-dimensional visualization of digital images to aid clinicians in their analysis of anatomy and pathology. The Vitrea Advanced Visualization user interface follows typical clinical workflow patterns to process, review, and analyze digital images, including: • Retrieve image data over the network via DICOM • Display of images in dedicated protocols which are automatically adapted based on exam type • Select images for closer examination from a gallery of 2D or 3D views • Interactively manipulate an image in real-time to visualize anatomy and pathology • Annotate, measure, and record selected views • Output selected views to standard film or paper printers, or post a report to an intranet web server or export views to another DICOM device • Retrieve reports that are archived on a Web server

Canon Medical Informatics, Inc.

Radiological PACS software

• Primary Device ID: 00850025268295
• NIH Device Record Key: 4d0bd99c-ac22-4df2-a166-f6b8e7a12ed6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Vitrea Advanced Visualization
• Version Model Number: 7.16.0.SU02
• Company DUNS: 160061651
• Company Name: Canon Medical Informatics, 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	00850025268295 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K032748

FDA Product Code

• LMD: System, Digital Image Communications, Radiological

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: 2024-08-21
• Device Publish Date: 2024-08-13

On-Brand Devices [Vitrea Advanced Visualization ]

• 00850025268127: The Vitrea Advanced Visualization software is a medical diagnostic system that allows the proces
• 00850025268080: The Vitrea Advanced Visualization software is a medical diagnostic system that allows the proces
• 00850025268158: The Vitrea Advanced Visualization software is a medical diagnostic system that allows the proces
• 00850025268110: The Vitrea Advanced Visualization software is a medical diagnostic system that allows the proces
• 00850025268202: The Vitrea Advanced Visualization software is a medical diagnostic system that allows the proces
• 00850025268165: The Vitrea Advanced Visualization software is a medical diagnostic system that allows the proces
• 00850025268219: The Vitrea Advanced Visualization software is a medical diagnostic system that allows the proces
• 00850025268226: The Vitrea Advanced Visualization software is a medical diagnostic system that allows the proces
• 00850025268233: The Vitrea Advanced Visualization software is a medical diagnostic system that allows the proces
• 00850025268240: The Vitrea Advanced Visualization software is a medical diagnostic system that allows the proces
• 00850025268295: The Vitrea Advanced Visualization software is a medical diagnostic system that allows the proces
• 00850025268301: The Vitrea Advanced Visualization software is a medical diagnostic system that allows the proces