Vitrea Advanced Visualization - The Vitrea Advanced Visualization software is a - Canon Medical Informatics, Inc.

Duns Number:160061651

Device Description: The Vitrea Advanced Visualization software is a medical diagnostic system that allows the 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

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More Product Details

Catalog Number

-

Brand Name

Vitrea Advanced Visualization

Version/Model Number

7.12.5

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

-

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code Details

Product Code

JAK

Product Code Name

System, X-Ray, Tomography, Computed

Device Record Status

Public Device Record Key

6703dcf7-295d-4fba-8d3f-30082c77228c

Public Version Date

April 26, 2022

Public Version Number

2

DI Record Publish Date

November 23, 2020

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"CANON MEDICAL INFORMATICS, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 38
2 A medical device with a moderate to high risk that requires special controls. 33