Catalog Number

-

Brand Name

Viz ICH

Version/Model Number

Viz ICH Software

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K210209,K210209

Product Code

QAS

Product Code Name

Radiological Computer-Assisted Triage And Notification Software

Public Device Record Key

4aea1295-ca5c-4d91-ad01-5392dfa57352

Public Version Date

August 29, 2022

Public Version Number

3

DI Record Publish Date

April 06, 2022

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-