Vitrea - Vitrea is a medical diagnostic system that allows - Canon Medical Informatics, Inc.

Duns Number:160061651

Device Description: Vitrea is a medical diagnostic system that allows the processing, review, analysis, commun Vitrea 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 system provides multi-dimensional 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, including:Retrieve image data over the network via DICOMDisplay images that are automatically adapted to exam type via dedicated protocolsSelect images for closer examination from a gallery of up to six 2D or 3D viewsInteractively manipulate an image in real-time to visualize anatomy and pathologyAnnotate, tag, measure, and record selected viewsOutput selected views to standard film or paper printers, or post a report to an intranet web server or export views to another DICOM deviceRetrieve reports that are archived on a Web server

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More Product Details

Catalog Number

-

Brand Name

Vitrea

Version/Model Number

7.3.1

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

K032748,K052632,K071331,K071362,K072821,K121213,K122578,K140395,K141302,K143079,K150104,K150258,K151283,K151919,K160150,K161419

Product Code Details

Product Code

JAK

Product Code Name

System, X-Ray, Tomography, Computed

Device Record Status

Public Device Record Key

13c415b0-62a5-4ba1-992c-6fe7663121fe

Public Version Date

April 26, 2022

Public Version Number

6

DI Record Publish Date

October 12, 2016

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