Catalog Number

-

Brand Name

Change Healthcare Enterprise Imaging Network™ Viewer

Version/Model Number

1.0.4

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

July 16, 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

d45ab2c0-ec4c-499f-9ee7-99c7a1153cef

Public Version Date

July 19, 2021

Public Version Number

2

DI Record Publish Date

May 21, 2021

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-