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 DICOM, Display images that are automatically adapted to exam type via dedicated protocols,Select images for closer examination from a gallery of up to six 2D or 3D views,Interactively manipulate an image in real-time to visualize anatomy and pathology,Annotate, tag, 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.
Catalog Number
-
Brand Name
Vitrea
Version/Model Number
7.5
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
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"
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For Single-Use
-
Prescription Use (Rx)
-
Over the Counter (OTC)
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Kit
-
Combination Product
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Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
JAK
Product Code Name
System, X-Ray, Tomography, Computed
Public Device Record Key
929886f0-9e90-4b4a-a30a-ed933a392a7f
Public Version Date
April 26, 2022
Public Version Number
5
DI Record Publish Date
May 04, 2017
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
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 |