Catalog Number

VIXWINPL

Brand Name

Gendex VixWin™ imaging software

Version/Model Number

3

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K060178

Product Code

LLZ

Product Code Name

System, image processing, radiological

Public Device Record Key

8a30a133-41df-4ac1-b756-6a378d8bdda5

Public Version Date

January 31, 2022

Public Version Number

5

DI Record Publish Date

April 14, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-