Catalog Number

-

Brand Name

Change Healthcare Enterprise Imaging Network Viewer

Version/Model Number

1.0.1

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

April 12, 2021

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

K181185

Product Code

LLZ

Product Code Name

System, Image Processing, Radiological

Public Device Record Key

21107e3a-3f0f-4eb5-b030-416d973e02ea

Public Version Date

April 13, 2021

Public Version Number

2

DI Record Publish Date

January 26, 2021

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-