Catalog Number

-

Brand Name

Viz LVO

Version/Model Number

1.2

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

March 16, 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

6dd0e539-798e-44a7-8e31-351446e61657

Public Version Date

January 13, 2022

Public Version Number

3

DI Record Publish Date

January 28, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-