Duns Number:160061651
Device Description: Vitrea® software is an advanced visualization solution from Vital that creates 2D, 3D, and Vitrea® software is an advanced visualization solution from Vital that creates 2D, 3D, and 4D images of human anatomy from image data from multiple modalities. With this tool, physicians can easily navigate within these images to better understand disease conditions. Vitrea addresses specialists’ needs through various software options for cardiac, colon, vessel probe, and other applications. In addition, Vitrea software utilizes an intuitive clinical workflow and automatic settings to improve speed and simplicity.
Catalog Number
-
Brand Name
Vitrea
Version/Model Number
7.3.2
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"
-
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,K151115,K151283,K151919,K160150,K161157,K161419
Product Code
JAK
Product Code Name
System, X-Ray, Tomography, Computed
Public Device Record Key
056965df-2235-4585-ac8a-9a14f516ab72
Public Version Date
April 26, 2022
Public Version Number
6
DI Record Publish Date
December 22, 2016
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 |