Catalog Number
-
Brand Name
Viz LVO
Version/Model Number
1.4
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
May 05, 2019
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
DEN170073,DEN170073
Product Code
QAS
Product Code Name
Radiological computer-assisted triage and notification software
Public Device Record Key
da3aa6fd-e1a1-46e3-baa0-55de24aaea6e
Public Version Date
January 13, 2022
Public Version Number
3
DI Record Publish Date
April 09, 2019
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. | 20 |