Catalog Number

-

Brand Name

Change Healthcare Stratus Imaging PACS

Version/Model Number

0.7.0

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

April 26, 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

K203249

Product Code

LLZ

Product Code Name

System, Image Processing, Radiological

Public Device Record Key

5da3cd79-17ac-4254-9a54-9e2f244e12f8

Public Version Date

April 27, 2022

Public Version Number

2

DI Record Publish Date

January 31, 2022

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-