Duns Number:046672032
Device Description: Visualize:Vascular is software that renders 3D images of vascular segments from ultrasound Visualize:Vascular is software that renders 3D images of vascular segments from ultrasound imaging.
Catalog Number
INITVV
Brand Name
Visualize:Vascular
Version/Model Number
1.2
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
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
K103761,K103761
Product Code
LLZ
Product Code Name
System, Image Processing, Radiological
Public Device Record Key
a47ca54e-2a3d-4f6d-bf20-2c540b983746
Public Version Date
June 14, 2021
Public Version Number
1
DI Record Publish Date
June 04, 2021
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 |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 1 |