Catalog Number

-

Brand Name

Change Healthcare Stratus Imaging Viewer

Version/Model Number

1.0.8

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

February 16, 2022

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

bb8cbe81-e4de-46bd-85cc-572ebba69a3d

Public Version Date

February 17, 2022

Public Version Number

2

DI Record Publish Date

September 29, 2021

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-